FDA.reportPublic FDA data

BIOlogical52

Primary DI
10850065007820
Brand
BIOlogical52
Company
HF ACQUISITION CO. LLC
Model
3702
Catalog number
3702
Device description
Biological Indicator Mail-in Monitoring Test Strips
Published
2016-12-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRCIndicator, Biological Sterilization Process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRCIndicator, Biological Sterilization ProcessGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50850065007828PackageGS110In Commercial Distribution
10850065007820PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5085006500782850850065007828
1085006500782010850065007820

GMDN Terms#

Term, Definition table
TermDefinition
Biological sterilization indicatorA sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Dispose of expired spore strips in a landfill or incinerator.
Special Storage Condition, Specify00Sterilize expired spore strips and culture media before disposal.
Special Storage Condition, Specify00Store away from sterilizing units and other heat sources or chemical products.
Special Storage Condition, Specify00Store in a cool, dry place.

Contacts#

Phone, Email table
PhoneEmail
800-331-1984CustomerService@Healthfirst.com

Regulatory Flags#

DUNS number
045657305
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850065007540STAT KIT SM5 EMERGENCY MEDICAL KITSTAT KIT SM5 EMERGENCY MEDICAL KIT10244702026-01-05
00850065007557HSM STAT KIT 550 EMERGENCY MEDICAL KITHSM STAT KIT 550 EMERGENCY MEDICAL KIT10245102026-01-05
00850065007564HSM STAT KIT 550-AI EMERGENCY MEDICAL KITHSM STAT KIT 550-AI EMERGENCY MEDICAL KIT10245502026-01-05
00850065007489SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS10237702025-06-23
00850065007496SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS10237802025-06-23
00850065007434Criti-Kit 200-AICriti-Kit 200-AI1022670 2024-06-14
00850065007465Criti-Kit Narcan Opioid Overdose Kit – 2 DosesCriti-Kit Narcan Opioid Overdose Kit 10189402024-05-20
00850065007342MOBILE ACLS V2 EMERGENCY MEDICAL KIT100347110034712020-08-17
00850065007267SM ORGANIZERSM ORGANIZER10077612023-12-29
00850065007274STAT KIT SM7 EMERGENCY MEDICAL KITSTAT KIT SM710034912023-12-29
00850065007281STAT KIT SM10 EMERGENCY MEDICAL KITSTAT KIT SM1010035012023-12-29
00850065007298STAT KIT SM27 EMERGENCY MEDICAL KITSTAT KIT SM2710034812023-12-29
00850065007304STAT KIT SM30 EMERGENCY MEDICAL KITSTAT KIT SM3010035112023-12-29
00850065007311STAT KIT 550 EMERGENCY MEDICAL KITSTAT KIT 55010066112023-12-29
00850065007328STAT KIT 550-AI EMERGENCY MEDICAL KITSTAT KIT 550-AI10134012023-12-29
00850065007335STAT KIT 750 EMERGENCY MEDICAL KITSTAT KIT 75010065512023-12-29
00850065007359STAT KIT 750-AI EMERGENCY MEDICAL KITSTAT KIT 750-AI 10065612023-12-29
00850065007397STAT KIT Z-1000 MOBILE ACLS EMERGENCY MEDICAL KITSTAT KIT Z-1000 MOBILE ACLS10221002023-12-29
00850065007403CRITI-KIT 200 EMERGENCY MEDICAL KITCRITI-KIT 200 10035412023-12-29
00850065007410SM7 SELECT EMERGENCY MEDICAL KITSTAT KIT SM7 SELECT10183512023-12-29

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Primary DI, Brand, Company table
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107073878151173M™ Attest™3M COMPANYFRC2026-04-10
107073878151243M™ Attest™3M COMPANYFRC2026-04-10
307073878129123M™ Attest™3M COMPANYFRC2026-04-10
307073878129363M™ Attest™3M COMPANYFRC2026-04-10
307073878129433M™ Attest™3M COMPANYFRC2026-04-10
307073878129503M™ Attest™3M COMPANYFRC2026-04-10
07798375773607BIOTRACE™TERRAGENE S.A.FRC2026-03-10
10705037071319ULTRA GI™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FRC2025-12-15
07798164670070Bionova®TERRAGENE S.A.FRC2025-10-16
07798164670209Bionova®TERRAGENE S.A.FRC2025-10-16
07798164673545Bionova®TERRAGENE S.A.FRC2025-10-16
07798375773539ProEdgeTERRAGENE S.A.FRC2025-10-16
10686864061257AssureCheck™TERRAGENE S.A.FRC2025-10-16
07798375773034BIOTRACE™TERRAGENE S.A.FRC2025-03-06
M9850141001Spore StripMESA LABORATORIES, INC.FRC2025-01-15
M9850161001Spore Strip - EO/Dry HeatMESA LABORATORIES, INC.FRC2025-01-15
M9850341001Spore StripMESA LABORATORIES, INC.FRC2025-01-15
M9850351001Spore Strip Steam & ChemiclaveMESA LABORATORIES, INC.FRC2025-01-15
M9850361001Spore Strip Steam & ChemiclaveMESA LABORATORIES, INC.FRC2025-01-15
M985051000C1Dual Spore Strips - ControlMESA LABORATORIES, INC.FRC2025-01-15
M985051000T1Dual Spore Strips - TestMESA LABORATORIES, INC.FRC2025-01-15
M985055100T1Dual Spore Strip - TestMESA LABORATORIES, INC.FRC2025-01-15
M985HFY5201017950 HealthFirst Mail-In Spore Testing Service, 52 TestsMESA LABORATORIES, INC.FRC2024-12-18
07798375772624BIOTRACE™TERRAGENE S.A.FRC2024-11-12
07798375772945BIOTRACE™TERRAGENE S.A.FRC2024-11-12
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