Identity
- Trade Name
- MEDLINE FDA UDI
- Generic Name
- Insulin syringe/needle, safety FDA UDI
- Device Name
- SYR W/NDLE,SAFETY,INSLN,1ML,29GX0.5" FDA UDI
- Model / Reference
- SYRSI101292 FDA UDI
- Description
- SYR W/NDLE,SAFETY,INSLN,1ML,29GX0.5" FDA UDI
Identifiers
- Catalog Number
- SYRSI101292 FDA UDI
- Primary DI / UDI-DI
- 10888277657298 FDA UDI
- FDA Product Code
- MEG FDA UDIFMF FDA UDI
- GMDN Term
- Insulin syringe/needle, safety 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
Dimensions & Sizes
- Size
- Length — 0.5 Inch FDA UDITotal Volume — 1 Milliliter FDA UDIWeight — 29 Gram FDA UDI
Category: Insulin syringe/needle, safety
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Insulin syringe/needle, safety.
- SecureSafe Syringe With Safety Needle — Dynarex Corp. · Class II
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- RELI — MYCO MEDICAL SUPPLIES INC. · Class II
- ONE-CARE Safety Pen Needles 30G x 8mm, Yellow, — MediVena, LLC · Class II
- Endure — ENDURE INDUSTRIES, INC. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Disposable Insulin Syringe — Berpu Medical Technology Co., Ltd · Class II
- RELI — MYCO MEDICAL SUPPLIES INC. · Class II
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
K151991 also covers:
- 8943 SecureSafe Safety Blood Collection Set w/ Tube Holder, 21G, 3/4" Needle, 4/ — Dynarex Corp.
- 8944 SecureSafe Safety Blood Collection Set w/ Tube Holder, 23G, 3/4" Needle, 4/ — Dynarex Corp.
- 8945 SecureSafe Safety Blood Collection Set w/ Tube Holder, 25G, 3/4" Needle, 4/ — Dynarex Corp.
- Blood Collection Set — Dynarex Corp.
- Blood Collection Set — Dynarex Corp.
- Blood Collection Set — Dynarex Corp.
- CAINA — Jiangsu Caina Medical Co., Ltd
- CAINA — Jiangsu Caina Medical Co., Ltd
- CAINA — Jiangsu Caina Medical Co., Ltd
- CAINA — Jiangsu Caina Medical Co., Ltd
- SafeTPoint — Jiangsu Caina Medical Co., Ltd
- SafeTPoint — Jiangsu Caina Medical 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
- Medline Industries, Inc.
Sources (1)
- FDA UDI f9891dcc-923c-4c0e-9aa7-9df967cb06f0 37 fields · synced May 30, 2026