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Mini-Spike®

FDA UDI

Class II (US FDA UDI)

by B. Braun Medical Inc.

Identity

Trade Name
Mini-Spike® FDA UDI
Generic Name
Vial/bottle adaptor, non-hermetic FDA UDI
Device Name
MINI-SPIKE® Dispensing Pin with SAFSITE® Valve FDA UDI
Model / Reference
412000 FDA UDI
Description
MINI-SPIKE® Dispensing Pin with SAFSITE® Valve FDA UDI

Identifiers

Catalog Number
412000 FDA UDI
Primary DI / UDI-DI
04022495769619 FDA UDI
FDA Product Code
FPA FDA UDI
LHI FDA UDI
GMDN Term
Vial/bottle adaptor, non-hermetic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5440 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: Vial/bottle adaptor, non-hermetic

Mini-Spike® by B. Braun Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vial/bottle adaptor, non-hermetic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 278d1da4-9878-42a6-8d9e-e4a5269bef31 35 fields · synced May 30, 2026