Identity
- Trade Name
- Medline FDA UDI
- Generic Name
- Phlebotomy kit FDA UDI
- Device Name
- DBD-SYR W/NDLE,HYPODERM,27GX 1/2", 0.5ML FDA UDI
- Model / Reference
- SYR193272 FDA UDI
- Description
- DBD-SYR W/NDLE,HYPODERM,27GX 1/2", 0.5ML FDA UDI
Identifiers
- Catalog Number
- SYR193272 FDA UDI
- Primary DI / UDI-DI
- 10888277726659 FDA UDI
- 510(k) Number
- K150758 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Phlebotomy kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 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
No
FDA UDI
Category: Phlebotomy kit
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Phlebotomy kit.
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- Aero-Med — AERO-MED LLC · Class I
- Aero-Med — AERO-MED LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- Aero-Med — AERO-MED LLC · Class I
- Aero-Med — AERO-MED LLC · Class I
Cleared under the same submission
K150758 also covers:
- Glucertain — CellEra, LLC
- Glucertain — CellEra, LLC
- Secure Safe Allergy Tray — Dynarex Corp.
- SecureSafe Tuberculin Safety Syringe — Dynarex Corp.
- SecureSafe Tuberculin Safety Syringe — Dynarex Corp.
- SecureSafe Tuberculin Safety Syringe — Dynarex Corp.
- Metier — Jiangsu Caina Medical Co., Ltd
- Metier — Jiangsu Caina Medical Co., Ltd
- Metier — Jiangsu Caina Medical Co., Ltd
- Metier — Jiangsu Caina Medical Co., Ltd
- MEDLINE — MEDLINE INDUSTRIES, INC.
- ONE-CARE Insulin Safety Syringes — MediVena, LLC
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
- Medline Industries, Inc.
Sources (1)
- FDA UDI 53a2605a-efef-44cf-ab80-8a3c638a7b24 36 fields · synced May 30, 2026