BD Ultra-Fine

FDA UDI

Class II (US FDA UDI)

by Becton Dickinson And Company

Identity

Trade Name: BD Ultra-Fine FDA UDI
Generic Name: Insulin syringe/needle, basic FDA UDI
Device Name: BD Insulin Syringes with BD Ultra-Fine Needle, U-100, 8mm, 31G, 1mL FDA UDI
Model / Reference: 328289 FDA UDI
Description: BD Insulin Syringes with BD Ultra-Fine Needle, U-100, 8mm, 31G, 1mL FDA UDI

Identifiers

Catalog Number: 328289 FDA UDI
Primary DI / UDI-DI: 30382903282891 FDA UDI
FDA Product Code: FMF FDA UDI
GMDN Term: Insulin syringe/needle, basic 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 8 Millimeter FDA UDI
Needle Gauge — 31 Gauge FDA UDI
Total Volume — 1 Milliliter FDA UDI

Category: Insulin syringe/needle, basic

BD Ultra-Fine by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 27005976-efbf-4621-a83b-fe1a727afa72 36 fields · synced Jun 1, 2026