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SRI Healthcare

FDA UDI

Class II (US FDA UDI)

by SRI Healthcare, LLC

Identity

Trade Name
SRI Healthcare FDA UDI
Generic Name
Infant blanket, single-use FDA UDI
Device Name
NICU Pack, Vidant East Care FDA UDI
Model / Reference
129032 FDA UDI
Description
NICU Pack, Vidant East Care FDA UDI

Identifiers

Catalog Number
129032 FDA UDI
Primary DI / UDI-DI
00810019800399 FDA UDI
FDA Product Code
LRO FDA UDI
GMDN Term
Infant blanket, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4370 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

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: Infant blanket, single-use

SRI Healthcare by SRI Healthcare, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Infant blanket, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
SRI Healthcare, LLC

Sources (1)

  • FDA UDI ab41a005-b4cc-4186-bf59-3c7d78f536e2 35 fields · synced Jun 6, 2026