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FetaLink

FDA UDI

Class II (US FDA UDI)

by Cerner Corporation

Identity

Trade Name
FetaLink FDA UDI
Generic Name
Obstetrical monitoring/analysis software FDA UDI
Model / Reference
FetaLink 200 FDA UDI

Identifiers

Catalog Number
10000085 FDA UDI
Primary DI / UDI-DI
00850017753129 FDA UDI
510(k) Number
K091251 FDA UDI
FDA Product Code
HGM FDA UDI
GMDN Term
Obstetrical monitoring/analysis software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.2740 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Obstetrical monitoring/analysis software

FetaLink by Cerner Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Obstetrical monitoring/analysis software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cerner Corporation

Sources (1)

  • FDA UDI 12550e57-13bd-49ae-8c62-17a8b7392756 34 fields · synced Jun 1, 2026