Infant Heel Warmer 1223

GUDID 00850018561594

Infant Heel Warmer

INTERNATIONAL BIOMEDICAL, LTD.

Activated-medium surgical warming blanket
Primary Device ID00850018561594
NIH Device Record Keya91123b6-aed8-4c1b-9be2-a35da18f8702
Commercial Distribution StatusIn Commercial Distribution
Brand NameInfant Heel Warmer
Version Model Number1223
Catalog Number1223
Company DUNS073179368
Company NameINTERNATIONAL BIOMEDICAL, LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850018561594 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MPOInfant Heel Warmer (Chemical Heat Pack)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-28
Device Publish Date2023-06-20

Devices Manufactured by INTERNATIONAL BIOMEDICAL, LTD.

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00850018561594 - Infant Heel Warmer2023-06-28Infant Heel Warmer
00850018561594 - Infant Heel Warmer2023-06-28 Infant Heel Warmer
00850018561600 - Infant Heel Snuggler2023-06-28 Infant Heel Snuggler
00850018561648 - NeoPod T, Neonatal Transport Humidification System2023-06-28 Neonatal Transport Humidification System
00865648000306 - Aviator Transport Incubator2023-06-28 Aviator Transport Incubator
00865648000313 - NuBorne Infant Warmer2023-06-28 NuBorne Infant Warmer

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