FDA.reportPublic FDA data

Culture Media, 300/BX

Primary DI
00732224723181
Brand
Culture Media, 300/BX
Company
CROSSTEX INTERNATIONAL, INC.
Model
CM-300/300L
Device description
Culture Media, 300/BX
Published
2020-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
10732224723188PrimaryGS10
00732224723181Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1073222472318810732224723188
00732224723181007322247231817322247231810732224723181

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(585)359-0130info@spsmedical.com

Regulatory Flags#

DUNS number
057728685
Device count
300
DM exempt
true
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

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50732224004988Safe-Flo Plus Saliva EjectorM1003CLWHM1003CLWH2024-11-22
50732224005015Safe-Flo Plus Saliva EjectorM1004WHGRM1004WHGR2024-11-22
50732224005022Safe-Flo Plus Saliva EjectorM1005WHPKM1005WHPK2024-11-22
00732224005508DentaPure 365-Day Independent Water Bottle Cartridge*DP365B102022-11-21
00732224005515DentaPure Water Purification Municipal Cartridge*DP365M102022-11-21
00732224005522DentaPure Water Purification Bottle Cartridge*DP40B102022-11-21
00732224005690CrosstexZFFAD-100ZFFAD-1002024-04-19
00732224721484Sporview 10 Hour Self Contained BISVT-504SVT-5042024-04-10
20815878025321Burkhart Non-Woven SpongesENCNWLBK2024-04-09
20815878027585Burkhart Non-Woven SpongesENC100BK2024-04-09
20815878027592Burkhart Cotton RollsDNACBK2024-04-09
20815878028483Burkhart Non-Woven SpongesENC4NWLBK2024-04-09
10732224005673DentaPure Water Purification Bottle CartridgeDPI365B2024-04-08
10732224005680DentaPure Water Purification Municipal CartridgeDPI365M2024-04-08
00732224005676DentaPure Water Purification Bottle CartridgeDPI365B102024-04-08
00732224005683DentaPure Water Purification Municipal CartridgeDPI365M102024-04-08
10732224001736Articulating PaperTPTH2022-09-29

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