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K-Systems

FDA UDI

Class II (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name
K-Systems FDA UDI
Generic Name
Laminar airflow hood FDA UDI
Device Name
L126 IVF, Standard Heat Right FDA UDI
Model / Reference
6.111.211.121 FDA UDI
Description
L126 IVF, Standard Heat Right FDA UDI

Identifiers

Primary DI / UDI-DI
00888937023817 FDA UDI
FDA Product Code
PUB FDA UDI
GMDN Term
Laminar airflow hood FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.6120 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Laminar airflow hood

K-Systems by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laminar airflow hood.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
CooperSurgical, Inc.

Sources (1)

  • FDA UDI 1d9b129f-6d43-49be-9402-175bbf69aa77 33 fields · synced Jun 9, 2026