B-COOL CRYO WRAP 24" W/2,2.0 PKS

GUDID 00840314812728

Hausmann Enterprises, LLC

Hot/cold therapy pack, single-use
Primary Device ID00840314812728
NIH Device Record Key6ef56a60-0058-4191-8026-4e6e95d0317a
Commercial Distribution StatusIn Commercial Distribution
Brand NameB-COOL CRYO WRAP 24" W/2,2.0 PKS
Version Model NumberHM3397
Company DUNS001892660
Company NameHausmann Enterprises, LLC
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840314812728 [Primary]

FDA Product Code

IMEPack, Hot Or Cold, Reusable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-09
Device Publish Date2025-01-01

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