Preemie Transport Blanket 1126

GUDID 10714646000481

Preemie Transport Blanket, Very Low Birth Weight Blankets - 15ct

Bionix, LLC

Infant blanket, single-use Infant blanket, single-use Infant blanket, single-use Infant blanket, single-use Infant blanket, single-use Infant blanket, single-use Infant blanket, single-use Infant blanket, single-use Infant blanket, single-use Infant blanket, single-use Infant blanket, single-use Infant blanket, single-use Infant blanket, single-use Infant blanket, single-use Infant blanket, single-use
Primary Device ID10714646000481
NIH Device Record Keyae3c522e-c440-41fe-8d57-ed46f613dd21
Commercial Distribution StatusIn Commercial Distribution
Brand NamePreemie Transport Blanket
Version Model Number1126
Catalog Number1126
Company DUNS117844489
Company NameBionix, LLC
Device Count15
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com
Phone+1(800)551-7096
EmailBionix@bionix.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100714646000484 [Primary]
GS110714646000481 [Unit of Use]

FDA Product Code

KMEBEDDING, DISPOSABLE, MEDICAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-27
Device Publish Date2023-07-19

On-Brand Devices [Preemie Transport Blanket]

00714646000521Sample, Preemie Transport Blanket, Very Low Birth Weight Blanket
00714646000514Sample, Preemie Transport Blanket, Low Birth Weight Blanket
20714646000495Preemie Transport Blanket, Low Birth Weight Blankets - 15ct
10714646000481Preemie Transport Blanket, Very Low Birth Weight Blankets - 15ct

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.