Identity
- Trade Name
- ONE-CARE TB Safety Syringes FDA UDI
- Generic Name
- Metered-delivery hypodermic syringe/needle FDA UDI
- Device Name
- ONE-CARE Tuberculin Safety Syringes with fixed needle are sterile, single use devices intended for injection of fluids into the body. Designed to aid in prevention of needle stick injuries. They provide users with audible indication when the shield is pushed forward and then turned right or left to permanently lock the needle (''Click''). Large barrel flanges allow for secured grip and control of dosing. FDA UDI
- Model / Reference
- ONE-CARE TB Safety Syringes, 1mL, 28G x 0.5’’ FDA UDI
- Description
- ONE-CARE Tuberculin Safety Syringes with fixed needle are sterile, single use devices intended for injection of fluids into the body. Designed to aid in prevention of needle stick injuries. They provide users with audible indication when the shield is pushed forward and then turned right or left to permanently lock the needle (''Click''). Large barrel flanges allow for secured grip and control of dosing. FDA UDI
Identifiers
- Catalog Number
- 2107 FDA UDI
- Primary DI / UDI-DI
- 00810008214107 FDA UDI
- 510(k) Number
- K150758 FDA UDI
- FDA Product Code
- MEG FDA UDI
- GMDN Term
- Metered-delivery hypodermic syringe/needle 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
No
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
- Total Volume — 1 Milliliter FDA UDINeedle Gauge — 28 Gauge FDA UDILength — 0.5 Inch FDA UDI
Category: Metered-delivery hypodermic syringe/needle
ONE-CARE TB Safety Syringes by MediVena, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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.
- Medline — MEDLINE INDUSTRIES, INC.
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
- MediVena, LLC
Sources (1)
- FDA UDI f323f77b-4630-4f25-8d93-876cc556f684 38 fields · synced May 30, 2026