SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS

GUDID 00850065007496

HF ACQUISITION CO. LLC

Biological sterilization indicator
Primary Device ID00850065007496
NIH Device Record Key6cfe571e-10d6-40cb-8bfc-cbbbe441b83d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS
Version Model Number1023780
Company DUNS045657305
Company NameHF ACQUISITION CO. LLC
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 Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone800-331-1984
Emailcustomerservice@healthfirst.com
Phone800-331-1984
Emailcustomerservice@healthfirst.com
Phone800-331-1984
Emailcustomerservice@healthfirst.com
Phone800-331-1984
Emailcustomerservice@healthfirst.com
Phone800-331-1984
Emailcustomerservice@healthfirst.com
Phone800-331-1984
Emailcustomerservice@healthfirst.com
Phone800-331-1984
Emailcustomerservice@healthfirst.com
Phone800-331-1984
Emailcustomerservice@healthfirst.com
Phone800-331-1984
Emailcustomerservice@healthfirst.com
Phone800-331-1984
Emailcustomerservice@healthfirst.com
Phone800-331-1984
Emailcustomerservice@healthfirst.com
Phone800-331-1984
Emailcustomerservice@healthfirst.com
Phone800-331-1984
Emailcustomerservice@healthfirst.com
Phone800-331-1984
Emailcustomerservice@healthfirst.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850065007496 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRCIndicator, Biological Sterilization Process

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-01
Device Publish Date2025-06-23

Devices Manufactured by HF ACQUISITION CO. LLC

00850065007489 - SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS2025-07-01
00850065007496 - SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS2025-07-01
00850065007496 - SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS2025-07-01
00850065007434 - Criti-Kit 200-AI2024-06-24
00850065007465 - Criti-Kit Narcan Opioid Overdose Kit – 2 Doses2024-05-28
00850065007267 - SM ORGANIZER2024-01-08
00850065007274 - STAT KIT SM7 EMERGENCY MEDICAL KIT2024-01-08
00850065007281 - STAT KIT SM10 EMERGENCY MEDICAL KIT2024-01-08
00850065007298 - STAT KIT SM27 EMERGENCY MEDICAL KIT2024-01-08

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