NuRoo

GUDID 00082161080077

Baby carrier

BROWNMED, INC.

Neonatal kangaroo care garment
Primary Device ID00082161080077
NIH Device Record Keyd58a6b75-f3d8-4080-9dbc-7a459fb59c22
Commercial Distribution StatusIn Commercial Distribution
Brand NameNuRoo
Version Model Number08007
Company DUNS091999771
Company NameBROWNMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100082161080077 [Primary]

FDA Product Code

HEFBinder, Breast

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-21
Device Publish Date2020-08-13

On-Brand Devices [NuRoo]

00849174080308Baby carrier
00849174080001Baby carrier
00082161082828Baby swaddle
00082161082811Baby swaddle
00082161082255Baby swaddle
00082161080084Baby carrier
00082161080077Baby carrier
00082161080060Baby carrier
00082161080053Baby carrier

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