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Baebies

FDA UDI

Class I (US FDA UDI)

by Baebies Inc.

Identity

Trade Name
Baebies FDA UDI
Generic Name
Newborn metabolic screen/congenital disorder IVD, control FDA UDI
Device Name
Quality Control Dried Blood Spot - Intermediate FDA UDI
Model / Reference
3369 FDA UDI
Description
Quality Control Dried Blood Spot - Intermediate FDA UDI

Identifiers

Catalog Number
3369 FDA UDI
Primary DI / UDI-DI
00819704020210 FDA UDI
FDA Product Code
JJY FDA UDI
GMDN Term
Newborn metabolic screen/congenital disorder IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Newborn metabolic screen/congenital disorder IVD, control

Baebies by Baebies Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Newborn metabolic screen/congenital disorder IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Baebies Inc.

Sources (1)

  • FDA UDI bb672205-1460-4b58-b2bb-54b101d6878a 36 fields · synced Jun 8, 2026