FDA.reportPublic FDA data

SporAmpule®

Primary DI
00816576022571
Brand
SporAmpule®
Company
HARDY DIAGNOSTICS
Model
BST100
Catalog number
BST100
Device description
For monitoring steam sterilization processes.
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
00816576022571PrimaryGS10
00816576022083Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816576022571008165760225718165760225710816576022571
00816576022083008165760220838165760220830816576022083

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
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-866-2222techservice@hardydiagnostics.com

Regulatory Flags#

DUNS number
039981550
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816576027958N/AW95W952020-06-08
00819398024594N/AY100Y1002020-06-08
00819398023603N/AR76BXR76BX2020-06-05
00819398024235HardyFlask™X26X262020-06-08
00816576027088HardyDisk™Z9491Z94912025-08-08
00816576026975HardyDisk™Z9485Z94852025-07-14
00816576027439 QwikIDIG06020C03IG06020C032025-06-23
00819398027199N/AZ134Z1342020-06-10
00819398027779N/AZ135Z1352020-06-10
00816576023516N/A102010202020-05-26
00816576025800TransPROTPV50TPV502024-10-08
00816576026951N/AG367G3672024-07-08
00816576026586N/AJ139J1392020-05-20
00816576026876N/AR12R122024-03-08
00819398021593N/AR63BXR63BX2024-01-15
00819398020602N/AK02K022020-05-24
00816576026838HardyCHROM™J28J282023-12-08
00816576024391AnaeroGROAG051AG0512020-05-12
00819398020725HardyDisk™Z9465Z94652023-11-21
00819398023627N/AR80R802020-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07798375773591BIOTRACE™TERRAGENE S.A.FRC2026-03-10
10705037066674STERRAD VELOCITY™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FRC2025-12-16
10705037066681STERRAD VELOCITY™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FRC2025-12-16
10705037066698STERRAD VELOCITY™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FRC2025-12-16
10705037066704STERRAD VELOCITY™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FRC2025-12-16
10705037066711STERRAD VELOCITY™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FRC2025-12-16
10705037070718ULTRA GI™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FRC2025-12-15
07798164677970Bionova®TERRAGENE S.A.FRC2025-08-01
07798164678069Bionova®TERRAGENE S.A.FRC2025-08-01
07798164678083Bionova®TERRAGENE S.A.FRC2025-08-01
07798164678090Bionova®TERRAGENE S.A.FRC2025-08-01
00850065007489SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTSHF ACQUISITION CO. LLCFRC2025-06-23
00850065007496SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTSHF ACQUISITION CO. LLCFRC2025-06-23
07798164674948Bionova®TERRAGENE S.A.FRC2025-04-25
07798164679103Bionova®TERRAGENE S.A.FRC2025-03-06
07798375772495BIOTRACE™TERRAGENE S.A.FRC2025-03-06
07798375772501BIOTRACE™TERRAGENE S.A.FRC2025-03-06
07798375773041BIOTRACE™TERRAGENE S.A.FRC2025-03-06
M9850141000Spore StripMESA LABORATORIES, INC.FRC2025-01-15
M9850161000Spore Strip - EO/Dry HeatMESA LABORATORIES, INC.FRC2025-01-15
M9850341000Spore StripMESA LABORATORIES, INC.FRC2025-01-15
M9850351000Spore Strip Steam & ChemiclaveMESA LABORATORIES, INC.FRC2025-01-15
M9850361000Spore Strip Steam & ChemiclaveMESA LABORATORIES, INC.FRC2025-01-15
M985051000C0Dual Spore Strips - ControlMESA LABORATORIES, INC.FRC2025-01-15
M985051000T0Dual Spore Strips - TestMESA LABORATORIES, INC.FRC2025-01-15
M985HFY1201017960 HealthFirst Mail-In Spore Testing Service, 12 TestMESA LABORATORIES, INC.FRC2024-12-18
07798375772877BIOTRACE™TERRAGENE S.A.FRC2024-11-12
07798375773003BIOTRACE™TERRAGENE S.A.FRC2024-11-12
07798375772990BIOTRACE™TERRAGENE S.A.FRC2024-11-12
00686864060895Medicom® AssureCheck™AMD Medicom IncFRC2024-10-14