Infa-Therm Mattress 1015

GUDID 00850018561587

Infa-Therm Infant Warming Mattress

INTERNATIONAL BIOMEDICAL, LTD.

Exothermic heat therapy pack/patch
Primary Device ID00850018561587
NIH Device Record Key62a4a2db-394a-4fd1-9a22-d29726295c1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameInfa-Therm Mattress
Version Model Number1015
Catalog Number1015
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850018561587 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IMDPack, Hot Or Cold, Disposable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-17
Device Publish Date2023-04-07

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