ONE-CARE - Single-use tube holder designed for use with blood collection tubes and compatible blood collection needles during venous blood specimen collection.
2026-09-11
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3013331067 | 3013331067 | MEDIVENA, LLC | 1 | Y | 2026-01-01 | 1 Glenlake Parkway Suite 700 Atlanta GA US 30328 |
| 3015485283 | 3015485283 | MEDIVENA SP. Z O.O. | 1 | N | 2026-01-01 | Aleja Jana Pawla II 27 Warszawa Mazowieckie PL 00-867 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00810008210147 | ONE-CARE Safety Lancets - ONE-CARE Safety Lancets 21G x 2.4mm, LowFlow, are sterile, single-use devices designed for capillary blood sampling, ensuring safety, precision, and comfort during the procedure. | 4045142586 | info@medivena.com |
| 00810008211502 | ONE-CARE Pen Needles - The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a compatible insulin pen injector. It consists of a fine, thin-wall needle with an integrated safety cap and a universal screw-on or snap-on connection for compatibility with most insulin pen devices. | 4045142586 | info@medivena.com |
| 00810008214015 | ONE-CARE Pen Needles - The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a compatible insulin pen injector. It consists of a fine, thin-wall needle with an integrated safety cap and a universal screw-on or snap-on connection for compatibility with most insulin pen devices. | 4045142586 | info@medivena.com |
| 00810008214275 | ONE-CARE Pen Needles - The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a compatible insulin pen injector. It consists of a fine, thin-wall needle with an integrated safety cap and a universal screw-on or snap-on connection for compatibility with most insulin pen devices. | 4045142586 | info@medivena.com |
| 00810008217221 | GLUCO-CARE PLUS Pen Needles - The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a compatible insulin pen injector. It consists of a fine, thin-wall needle with an integrated safety cap and a universal screw-on or snap-on connection for compatibility with most insulin pen devices | 4045142586 | info@medivena.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 326828 | 1997691970 | K222408 | Disposable Safety Lancet | FMK | 2022-11-29 |
| 326828 | 1133916286 | K222376 | Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) | FMK | 2022-10-03 |
| 326828 | 1789990150 | K222090 | Safety Lancet | FMK | 2022-09-30 |
| 326828 | 1546116395 | K221839 | Lancet | FMK | 2022-09-19 |
| 326828 | 1952952338 | K221178 | Disposable Insulin Pen Needle | FMI | 2022-11-17 |
| 326828 | 1295100129 | K220614 | MEDOJECT fine Pen Needles | FMI | 2022-06-15 |
| 326828 | 1116902888 | K213183 | Safety Insulin Pen Needles | FMI | 2022-10-14 |
| 326828 | 1257153261 | K201044 | CHIRANA Insulin Syringes | FMF | 2022-01-18 |
| 326828 | 1312611001 | K172763 | Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder | JKA | 2018-06-04 |
| 326828 | 1661766550 | K151991 | |||
| 326828 | 2047633433 | K133059 | INSULIN PEN NEEDLE | FMI | 2014-02-25 |
| 326828 | 1683807045 | K113091 |
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