H3 Cartridge 048400-10

GUDID 00856522006132

H3 Cartridge, 10 Count

Lifehealth

Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
Primary Device ID00856522006132
NIH Device Record Keycfde495f-5124-42ea-bfc6-aff2d0cbd2d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameH3 Cartridge
Version Model Number049220
Catalog Number048400-10
Company DUNS080886029
Company NameLifehealth
Device Count10
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-651-638-1000
Emailcs@lifehealthmed.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100856522006132 [Primary]
GS100856522006149 [Unit of Use]

FDA Product Code

GKGCentrifuge, Hematocrit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-05-24
Device Publish Date2018-04-23

On-Brand Devices [H3 Cartridge]

00856522006132H3 Cartridge, 10 Count
00856522006026H3 Cartridge, 25 count

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.