Frequently Asked Questions & Answers
Have a question about our products?
Find some of the answers here.
General FAQ
You can call 215-364-5582 and provide an Official PO Number or you can e-mail an Official PO or PO Number to sales@safe-tecllc.com and a representative will respond within 1 to 2 business days. Each product has a specific Minimum Order Quantity. A representative will provide pricing.
All products are manufactured in the United States of America.
Shipping Terms are FOB Origin, IncoTerms are ExWorks.
All Duties and Taxes are the responsibility of the Customer
The Title transfers to the Customer when the Order is picked up by the freight provider of the Customer’s choice.
Each Order is shipped using a Customer’s preferred freight provider and account number, or a Customer may use our FedEx Account with the charges added to each invoice.
All sales are final. We do not accept returns.
SAFECAP® FAQ
2 years from date of original manufacture.
2 to 5 business days for domestic orders depending on your proximity to Ivyland, PA and method of shipment – 5 to 8 business days for International Orders.
The recommended storage environment is room temperature. However, SAFECAP® has been exposed to both extreme heat (Above 120°F) and extreme cold (Below -20°F) with no adverse effects.
There is no maximum or minimum natural temperature limitation that has been validated.
SAFEPETTE® FAQ
No. SAFEPETTE® was specifically designed for use only with SAFECAP®.
SAFEPETTE® is a multi-use disposable item, there is no set number of dispensings that can be expected: a SAFEPETTE® could last for thousands of dispensings if used and maintained per instructions.
Each SAFEPETTE® reaches the end of its useful life at varying times depending on individual use, maintenance, or unforeseen factors such as dropping, hitting, incorrect SAFECAP® use, etc.
When a SAFEPETTE® ceases to function as intended it needs to be disposed of properly. Center managers will then need to order a new SAFEPETTE®.
There is no warranty on this product.
No. SAFEPETTE® must be sold as a cohesive unit. We do not sell its component parts.
Each SAFEPETTE® includes an IFU. Page 2 details how to properly maintain the SAFEPETTE®.
Dispenser maintenance should be performed daily when the dispenser is in constant use, or immediately following accidental tube breakage.
- Remove the sheath by grasping the black ring of the dispenser with one hand, while twisting and pulling the sheath with the other hand.
- Slide the black ring toward the plunger end to open the capillary tube locking mechanism.
- Gently tap the dispensing end (black tip) of the dispenser onto a hard surface to remove any glass particles that may be lodged in the dispenser tip.
- Wrap a tissue or gauze pad around the tip of the dispenser to contain overspray while lubricating.
- Insert one end of the red straw into the lubricant spray nozzle. Lubricate the dispenser by inserting the other end of the red straw into the tip of the dispenser and apply a quick squirt of aerosol CRC-56. Only a small amount is required.
- Wipe excess lubricant from the exterior of the dispenser tip with the tissue or gauze pad.
- After lubricating the dispenser, rinse the sheath with warm tap water and remount it on the dispenser. No waiting is required before reuse.
MICROSAFE® FAQ
MICROSAFE® is compatible with other aqueous fluids.
Our research and claims are based on handling blood samples ONLY. Some caustic fluids might react with the tube.
Samples can be provided for evaluation of compatibility with other aqueous fluids.
MICROSAFE® was not designed to be a storage or transportation container.
MICROSAFE® is free of latex, DEHP or BPA. An MSDS is available upon request.
No. MICROSAFE® is not coated with EDTA, or any other anti-coagulant.
MICROSAFE® is designed for Point of Care Tests; it is a pick-up and delivery system for fingerstick whole blood samples.
There is no issue with using MICROSAFE® if the anti-coagulant has no effect on the chemistries of your test.
The plastic raw material delays Factor XII of the coagulation cascade compared to glass.
Our recommendation is to collect and dispense the blood sample within 30 seconds.
MICROSAFE® is implemented worldwide in POC Tests by industry leaders without the need for anti-coagulant.
No. MICROSAFE® is intended for use in IVD procedures, therefore, only general standards of cleanliness apply (PART 820, SEC. 820.70, SUBPART G – PRODUCTION AND PROCESS CONTROLS / ISO 13485: 2016 – 7.5.1.2.1 “Cleanliness of product and contamination control”)
Anyone sterilizing MICROSAFE® post-purchase must use EtO (Ethylene Oxide Sterilization Process). MICROSAFE® has a melting point of 320°F and cannot withstand conventional high temperature steam sterilization.
4 years from date of original manufacture.
The recommended storage environment is ambient room temperature. This is only a recommendation, not a requirement.
MICROSAFE® is specifically designed for point of care testing in decentralized settings.
MICROSAFE® has been exposed to both extreme heat (Above 120°F) and extreme cold (Below -20°F) for extended periods with no adverse effects.
There is no maximum or minimum natural temperature limitation that has been validated.
MICROSAFE® is FDA and CE Registered. It is manufactured in accordance with ISO 13485: 2016 standards and 21CFR820. SAFE-TEC® also maintains a Health Canada Medical Device Establishment License.
The sample cannot be dispensed.
The sample will travel past the air vent and into the bulb. Discard that MICROSAFE® tube and use another MICROSAFE® tube.
Yes, MICROSAFE® is a Class I (general controls) medical device regulated under 21CFR864.6150 “Capillary blood collection tube. It is 510(k) exempt.