Identity
- Trade Name
- BD Allergy Syringe FDA UDI
- Generic Name
- General-purpose syringe, single-use FDA UDI
- Device Name
- SYRINGE ALLERGY 1ML W/NDL 26X1/2 IB FDA UDI
- Model / Reference
- 305538 FDA UDI
- Description
- SYRINGE ALLERGY 1ML W/NDL 26X1/2 IB FDA UDI
Identifiers
- Catalog Number
- 305538 FDA UDI
- Primary DI / UDI-DI
- 00382903055388 FDA UDI
- 510(k) Number
- K110771 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- General-purpose syringe, single-use 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: General-purpose syringe, single-use
BD Allergy Syringe by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General-purpose syringe, single-use.
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- HSW HENKE-JECT® — Henke-Sass, Wolf GmbH · Class II
- SURGYCO — Surgyco LLC · Class I
- Merit Medical® — Merit Medical Systems, Inc. · Class II
Cleared under the same submission
K110771 also covers:
- 1mL Allergist Syringe 27G 3/8IN Regular Bevel — BECTON DICKINSON AND COMPANY
- BD Allergy Syringe — BECTON DICKINSON AND COMPANY
- BD Allergy Syringe — BECTON DICKINSON AND COMPANY
- BD Luer-Lok — BECTON DICKINSON AND COMPANY
- BD Luer-Lok — BECTON DICKINSON AND COMPANY
- BD Luer-Lok — BECTON DICKINSON AND COMPANY
- BD Luer-Lok — BECTON DICKINSON AND COMPANY
- BD Luer-Lok — BECTON DICKINSON AND COMPANY
- BD Luer-Lok — BECTON DICKINSON AND COMPANY
- BD Luer-Lok — BECTON DICKINSON AND COMPANY
- BD Luer-Lok — BECTON DICKINSON AND COMPANY
- BD Luer-Lok — BECTON DICKINSON AND COMPANY
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
- Becton Dickinson And Company
Sources (1)
- FDA UDI 424f6ac8-9ec6-48d4-864c-6b54482035ac 36 fields · synced May 30, 2026