Identity
- Trade Name
- micsafe FDA UDI
- Generic Name
- Blood collection tube holder/needle FDA UDI
- Device Name
- SAFETY BLOOD COLLECTION NEEDLE WITH HOLDER 21Gx3/4" FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- SAFETY BLOOD COLLECTION NEEDLE WITH HOLDER 21Gx3/4" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971911291532 FDA UDI
- 510(k) Number
- K212019 FDA UDI
- FDA Product Code
- JKA FDA UDI
- GMDN Term
- Blood collection tube holder/needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blood collection tube holder/needle
micsafe by Jiangsu Micsafe Medical Tehcnology Co., LTD. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood collection tube holder/needle.
- ULTRAFLO-V — Innovative Medical Technologies, Inc. · Class II
- caina — Jiangsu Caina Medical Co., Ltd · Class II
- STRADIS HEALTHCARE — STRADIS MEDICAL, LLC · Class I
- RELI — MYCO MEDICAL SUPPLIES INC. · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class II
- ONE-CARE Safety Blood Collection Needles — MediVena, LLC · Class II
- Vacuette — Greiner Bio-One GmbH · Class II
- ONE-CARE Safety Blood Collection Needles — MediVena, LLC · Class II
Cleared under the same submission
K212019 also covers:
- micsafe — Jiangsu Micsafe Medical Tehcnology Co., LTD.
- micsafe — Jiangsu Micsafe Medical Tehcnology Co., LTD.
- micsafe — Jiangsu Micsafe Medical Tehcnology Co., LTD.
- micsafe — Jiangsu Micsafe Medical Tehcnology Co., LTD.
- micsafe — Jiangsu Micsafe Medical Tehcnology Co., LTD.
- micsafe — Jiangsu Micsafe Medical Tehcnology Co., LTD.
- micsafe — Jiangsu Micsafe Medical Tehcnology Co., LTD.
- micsafe — Jiangsu Micsafe Medical Tehcnology Co., LTD.
- micsafe — Jiangsu Micsafe Medical Tehcnology Co., LTD.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Jiangsu Micsafe Medical Tehcnology Co., LTD.
Sources (1)
- FDA UDI 24944281-c24a-4051-8c65-4f2eda103b2f 34 fields · synced May 30, 2026