BD Seditainer™ Stand

FDA UDI

Class II (US FDA UDI)

by Becton, Dickinson U.K. Limited

Identity

Trade Name: BD Seditainer™ Stand FDA UDI
Generic Name: Erythrocyte sedimentation rate (ESR) rack IVD, scaled measure FDA UDI
Device Name: ESR SEDITAINER TUBE STAND FOR 10 TUBES FDA UDI
Model / Reference: 366016 FDA UDI
Description: ESR SEDITAINER TUBE STAND FOR 10 TUBES FDA UDI

Identifiers

Catalog Number: 366016 FDA UDI
Primary DI / UDI-DI: 00382903660162 FDA UDI
510(k) Number: K953994 FDA UDI
FDA Product Code: JKA FDA UDI
GMDN Term: Erythrocyte sedimentation rate (ESR) rack IVD, scaled measure FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1675 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

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

FDA UDI

Manufacturing Date

FDA UDI

BD Seditainer™ Stand by Becton, Dickinson U.K. Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K953994 also covers:

BD Seditainer™ 0.105M 1.25ml Buffered Sodium Citrate Blood Collection Tubes — Becton, Dickinson U.K. Limited

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 U.K. Limited

Sources (1)

FDA UDI dee5c963-ba75-4c54-a8f1-d1d0eaecac86 37 fields · synced May 30, 2026