FDA.reportPublic FDA data

ET Foam

Primary DI
10850046436014
Brand
ET Foam
Company
Germiphene Corporation
Model
TRANS-FOAM-XXL
Catalog number
TRANS-FOAM-XXL
Device description
ET Foam - 4 liter
Published
2022-11-22
Public version status
New
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
JCBDETERGENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCBDetergentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850046436014PackageGS11In Commercial Distribution
20850046436011PackageGS14In Commercial Distribution
00850046436017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004643601410850046436014
2085004643601120850046436011
00850046436017008500464360178500464360170850046436017

GMDN Terms#

Term, Definition table
TermDefinition
Medical device cleaning agentA substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental and/or surgical instruments/devices for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds prior to disinfection or sterilization; it is not intended for in vitro diagnostic device use. It includes a detergent and may be added, as manufacturer specified, to water for cleaning and/or be applied directly to soiled devices immediately after their use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 265-9931info@germiphene.com

Regulatory Flags#

DUNS number
206412512
Device count
1
DM exempt
false
Premarket exempt
true
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
00850046436338ET FoamTRANS-FOAMTRANS-FOAM2024-03-13
00850046436307GobbleGOB-ASGOB-AS2022-12-19
00850046436314GobbleGOB-AS-TPGOB-AS-TP2022-12-19
00850046436000ET FoamTRANS-FOAMTRANS-FOAM2022-11-22
00850046436017ET FoamTRANS-FOAM-XXLTRANS-FOAM-XXL2022-11-22
00850046436024Surgical MilkSM-LSM-L2022-11-22
00850046436031Surgical MilkSM-SSM-S2022-11-22
00850046436086GleamGLEGLE2022-11-22
00850046436147MicrovacEX-G-MICROVAC-XXLEX-G-MICROVAC-XXL2022-11-22
00850046436161MicrovacG-MICROVAC-XXLG-MICROVAC-XXL2022-11-22
00850046436192Tres CleanDTR-MDTR-M2022-11-22
00850046436277Tres CleanTrTr2022-11-22
10850046436007ET FoamTRANS-FOAMTRANS-FOAM2022-11-22
10850046436021Surgical MilkSM-LSM-L2022-11-22
10850046436038Surgical MilkSM-SSM-S2022-11-22
00850046436048Surgical MilkSM-XLSM-XL2022-11-22
00850046436055ET FoamTRANSFOAM-DRTRANSFOAM-DR2022-11-22
00850046436062Surgical MilkSM-XXLSM-XXL2022-11-22
10850046436083GleamGLEGLE2022-11-22
00850046436093GleamGLE-DRUMGLE-DRUM2022-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740750622Detergent for Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JCB2026-04-16
06935740750639Detergent for Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JCB2026-04-16
06935740750646Detergent for Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JCB2026-04-16
08436583731888Grifols Wash Solution ADIAGNOSTIC GRIFOLS SAJCB2026-03-13
08436583731895Grifols Wash Solution BDIAGNOSTIC GRIFOLS SAJCB2026-03-13
06936415904678MR Detergent SolutionShenzhen Mindray Bio-Medical Electronics Co., Ltd.JCB2026-01-23
06936415904685MR Buffer SolutionShenzhen Mindray Bio-Medical Electronics Co., Ltd.JCB2026-01-23
06936415994457PROBE CLEANSERShenzhen Mindray Bio-Medical Electronics Co., Ltd.JCB2026-01-22
06944904030210PROBE CLEANSERShenzhen Mindray Bio-Medical Electronics Co., Ltd.JCB2026-01-22
159998600941705x TBS Wash BufferDiatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-12-11
059998600941735x TBS Wash BufferDiatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-12-11
15999883586751Atellica DT Solution 1 (S1)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-04-30
15999883586867Atellica DT Solution 4 (S4)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-04-30
45999883586752Atellica DT Solution 2 (S2)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-04-30
25999883586758Atellica DT Solution 1 (S1)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-04-30
15999883586850Atellica DT Solution 3 (S3)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-04-30
25999883586864Atellica DT Solution 4 (S4)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-04-30
55999883586759Atellica DT Solution 2 (S2)Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo ReszvenytarsasagJCB2025-04-30
00739470000011Micro-Scientific Enzyclean IIMICRO-SCIENTIFIC, LLCJCB2025-04-29
00739470000028Micro-Scientific EnzycleanMICRO-SCIENTIFIC, LLCJCB2025-04-29
00739470000066Micro-Scientific MicroKleen HSMICRO-SCIENTIFIC, LLCJCB2025-04-29
00739470000158Micro-Scientific Enzyclean II LSMICRO-SCIENTIFIC, LLCJCB2025-04-29
00739470000172Micro-Scientific MicroKleen LSMICRO-SCIENTIFIC, LLCJCB2025-04-29
00739470400163Micro-Scientific Enzyclean IVMICRO-SCIENTIFIC, LLCJCB2025-04-29
10739470000018Micro-Scientific Enzyclean IIMICRO-SCIENTIFIC, LLCJCB2025-04-29
10739470000025Micro-Scientific EnzycleanMICRO-SCIENTIFIC, LLCJCB2025-04-29
10739470000063Micro-Scientific MicroKleen HSMICRO-SCIENTIFIC, LLCJCB2025-04-29
10739470000155Micro-Scientific Enzyclean II LSMICRO-SCIENTIFIC, LLCJCB2025-04-29
10739470000179Micro-Scientific MicroKleen LSMICRO-SCIENTIFIC, LLCJCB2025-04-29
50739470400168Micro-Scientific Enzyclean IVMICRO-SCIENTIFIC, LLCJCB2025-04-29