FDA.reportPublic FDA data

PEPTONE WATER

Primary DI
05032384001071
Brand
PEPTONE WATER
Company
OXOID LIMITED
Model
CM0009B
Published
2024-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JSDCulture Media, Selective Broth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSDCulture Media, Selective BrothMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05032384001071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05032384001071050323840010715032384001071

GMDN Terms#

Term, Definition table
TermDefinition
Differential/selective agar culture medium IVDAn agar culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing on the same medium by appearance (e.g., colour, shape, growth pattern). It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
365355452
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05032384029600ANAEROJAR BASEAG0026A2022-12-12
05032384029044STAPHYTECT PLUSDR0850M2026-01-28
05032384029051STAPHYTECT PLUSDR0850B2026-01-28
05032384550784Thermo Scientific Oxoid Gepotidacin Disc (10 ug) GEP10CT1975B2026-01-21
05032384533121Oxoid Aztreonam/Avibactam Disc (30/20ug) AZA50CT1971B2025-12-12
05032384003914SELENITE CYST.BROTH BASECM0699B2025-07-23
05032384126453PEPTONE WATER (ANDRADE)CM0061B2025-06-27
05032384127993REAGENT SPOT INDOLE DMACAMB1448A2025-06-27
05032384502974IMAGEN Parainfluenza Virus Types 1, 2 and 3K610411-22024-12-30
05032384502981IMAGEN Influenza Virus A and BK610511-22024-12-30
05032384012039AMPICILLIN SELECTIVE SUPP. 1 X 10 VIALSSR0136E2022-12-02
05032384082919ORSAB SELECTIVE SUPPLEMENTSR0195E2024-10-29
05032384083237OXACILLIN RES. SCREENING AGAR BASECM1008B2024-10-29
05032384516018Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test DiscsCT1954B2024-10-28
05032384537723Oxoid Sulbactam/Durlobactam (10/10ug) SUD20 Antimicrobial Susceptibility Test DiCT1960B2024-10-28
05032384128006Microbact Staph 12SMB1561A2024-10-28
05032384128013Microbact Staph Fast Blue ReagentMB1588A2024-10-28
05032384580231Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test DiscsCT1954B2024-10-28
05032384579945Oxoid Sulbactam/Durlobactam (10/10ug) SUD20 Antimicrobial Susceptibility Test DiCT1960B2024-10-28
05700573075706NAK610611-22016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
38053326011772LBM CABrothCOPAN ITALIA SPAJSD2025-09-22
08053326011771LBM CABrothCOPAN ITALIA SPAJSD2025-09-22
05407010128642TSB 3%:10 L bag (empty bag capacity)Lonza VerviersJSD2025-09-15
05407010128666TSB 3%:1000 L bag (empty bag capacity)Lonza VerviersJSD2025-09-15
05407010128673TSB 3%:500 L bag (empty bag capacity)Lonza VerviersJSD2025-09-15
05407010128680TSB 3%:1 L bag SAMPLELonza VerviersJSD2025-09-15
05407010128697TSB 3%:50 L bag (empty bag capacity)Lonza VerviersJSD2025-09-15
05032384003914SELENITE CYST.BROTH BASEOXOID LIMITEDJSD2025-07-23
05407010127164Tryptic Soy Broth 15g/L 100mlLonza VerviersJSD2025-05-26
05407010127171Tryptic Soy Broth 15g/L 500mlLonza VerviersJSD2025-05-26
05407010127188Tryptic Soy Broth 15g/L, 500ML bagLonza VerviersJSD2025-05-26
05407010127195Tryptic Soy Broth 15g/L 2L in 20L bagLonza VerviersJSD2025-05-26
05407010127201Tryptic Soy Broth 15g/L - 5ml tubeLonza VerviersJSD2025-05-26
054070101272183% w/v TSB, 500 ml bag Sample close systLonza VerviersJSD2025-05-26
054070101272253% w/v TSB, 500 ml bag Sample open systLonza VerviersJSD2025-05-26
054070101272323% w/v TSB - 1 L bagLonza VerviersJSD2025-05-26
054070101272493% w/v TSB - 200 L bagLonza VerviersJSD2025-05-26
054070101272563% w/v TSB - 50 L bagLonza VerviersJSD2025-05-26
05407010127263Tryptic Soy Broth 1L bag - SAMPLELonza VerviersJSD2025-05-26
05407010127270Tryptic Soy Broth 200L bagLonza VerviersJSD2025-05-26
054070101272873% W/V TSB - 1L bag SampleLonza VerviersJSD2025-05-26
054070101272943% W/V TSB - 10L bagLonza VerviersJSD2025-05-26
05407010127300TSB 3% : 1L bag SAMPLELonza VerviersJSD2025-05-26
B645T0641EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSD2025-04-21
B645T0736EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSD2025-04-21
B645T0763EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSD2025-04-21
B645T0781EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSD2025-04-21
B645T2255EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSD2025-04-21
B645T06411EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSD2025-04-21
B645T07361EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSD2025-04-21