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Hcs

FDA UDI

Class I (US FDA UDI)

by Concordance Healthcare Solutions LLC

Identity

Trade Name
HCS FDA UDI
Generic Name
General specimen container IVD, no additive/medium FDA UDI
Device Name
8" x 10" Biohazard Specimen Bag, “Frozen/Refrigerate/Room Temperature” Ziplock, Dual Pouch, Clear FDA UDI
Model / Reference
HCS7011-O FDA UDI
Description
8" x 10" Biohazard Specimen Bag, “Frozen/Refrigerate/Room Temperature” Ziplock, Dual Pouch, Clear FDA UDI

Identifiers

Primary DI / UDI-DI
10810132041256 FDA UDI
FDA Product Code
NNI FDA UDI
GMDN Term
General specimen container IVD, no additive/medium FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.3250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: General specimen container IVD, no additive/medium

Hcs by Concordance Healthcare Solutions LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General specimen container IVD, no additive/medium.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Concordance Healthcare Solutions LLC

Sources (1)

  • FDA UDI 34360694-623e-450a-8b9e-92065113e7f9 33 fields · synced May 30, 2026