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Cardinal Health

FDA UDI

Class I (US FDA UDI)

by Cardinal Health 200, LLC

Identity

Trade Name
CARDINAL HEALTH FDA UDI
Generic Name
Amniocentesis kit, non-medicated FDA UDI
Device Name
AMNIOCENTESIS SPECIMEN VIAL PK FDA UDI
Model / Reference
SAM11SVHCC FDA UDI
Description
AMNIOCENTESIS SPECIMEN VIAL PK FDA UDI

Identifiers

Catalog Number
SAM11SVHCC FDA UDI
Primary DI / UDI-DI
10887488318295 FDA UDI
FDA Product Code
HIO FDA UDI
GMDN Term
Amniocentesis kit, non-medicated FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
884.1550 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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Amniocentesis kit, non-medicated

Cardinal Health by Cardinal Health 200, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Amniocentesis kit, non-medicated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardinal Health 200, LLC

Sources (1)

  • FDA UDI 3c701486-8b29-45a9-9996-d9b39dc95e23 34 fields · synced Jun 8, 2026