FDA.reportPublic FDA data

OxyPRAS Plus BBE/KVL Bi-Plate

Primary DI
00850056467025
Brand
OxyPRAS Plus BBE/KVL Bi-Plate
Company
Oxyrase, Inc.
Model
B-BCD-KV
Catalog number
B-BCD-KV
Device description
Culture Media, Selective and Non-Differential
Published
2023-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSJCULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSJCulture Media, Selective And Non-DifferentialMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850056467025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850056467025008500564670258500564670250850056467025

GMDN Terms#

Term, Definition table
TermDefinition
Multiple formulation agar culture medium IVDA combination of two or more selective, differential and/or enriched agar culture media formulations separately contained within a single petri dish (commonly referred to as a split plate) or dip slide and intended to be used for the simultaneous growth, selective isolation and/or differentiation of microorganisms from a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight24Gram

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
+1(419)589-8800l.stewart@oxyrase.com

Regulatory Flags#

DUNS number
157281882
Device count
1
Premarket exempt
true
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850056467124PEA OxyPlateO-PEA-BAO-PEA-BA2025-10-14
00850056467131OxyPRAS Plus StrictAna Blood Agar Plate with GentamycinP-SANA-BAP-SANA-BA2025-10-14
00850056467001OxyPRAS Plus Brucella Agar plateP-BRU-BAP-BRU-BA2023-11-30
00850056467018OxyPRAS Plus PEA PlateP-PEA-BAP-PEA-BA2023-11-30
00850056467032OxyPRAS Anaselect Blood Agar plateP-ANA-BAP-ANA-BA2023-11-30
00850056467049OxyPRAS Plus KVL plateP-KVL-BAP-KVL-BA2023-11-30
00850056467056OxyPRAS Plus Bile Esculin plateP-BBE-NBP-BBE-NB2023-11-30
00850056467063Schaedler Blood Agar OxyPlateO-SW-BAO-SW-BA2023-11-30
00850056467070KVL OxyPlateO-KVL-BAO-KVL-BA2023-11-30
00850056467087Modified Columbia Agar plateMCA-SMMCA-SM2023-11-30
00850056467094OxyPRAS Plus 3-pack: Brucella, PEA and BBE/KVL Bi-PlateM-BPBK-3M-BPBK-32023-11-30
00850056467100OxyPRAS Plus 3-pack, Brucella, PEA, and KVLM-BKP-3M-BKP-32023-11-30
00850056467117OxyPRAS Plus 2-pack, Brucella and BBE/KVL Bi-PlateM-BBK-2M-BBK-22023-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10382902149832BD BBL™ CHROMagar™ SalmonellaBECTON, DICKINSON AND COMPANYJSJ2026-04-03
10382902218729BD BBL™ TCBS AgarBECTON, DICKINSON AND COMPANYJSJ2026-04-03
B6453P395EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-21
B6451R009EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6453P275EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6453P390EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6454P256EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6454P330EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B645T0800EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-18
B6454P230EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-17
B645T0004EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-17
B645T0631EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSJ2025-04-17
10382902978791BD BBL™ BCYE Selective Agar w/PACBECTON, DICKINSON AND COMPANYJSJ2024-09-17
10382902981913BD BBL™ Inhibitory Mold Agar Deep FillBECTON, DICKINSON AND COMPANYJSJ2024-08-29
10382902216015BD BBL™ Columbia CNA Agar with 5% SB and BD BBL MacConkey II Agar BD I Plate™BECTON, DICKINSON AND COMPANYJSJ2024-08-23
00848838001048REMELREMEL, INC.JSJ2023-01-03
00848838001055REMELREMEL, INC.JSJ2023-01-03
00848838001086REMELREMEL, INC.JSJ2023-01-03
00848838001093REMELREMEL, INC.JSJ2023-01-03
00848838001116REMELREMEL, INC.JSJ2023-01-03
00848838001437REMELREMEL, INC.JSJ2023-01-03
00848838001451REMELREMEL, INC.JSJ2023-01-03
00848838000119REMELREMEL, INC.JSJ2022-12-30
00848838000201REMELREMEL, INC.JSJ2022-12-30
00848838000348REMELREMEL, INC.JSJ2022-12-30
00848838000355REMELREMEL, INC.JSJ2022-12-30
00848838000423REMELREMEL, INC.JSJ2022-12-30
00848838000430REMELREMEL, INC.JSJ2022-12-30
00848838000447REMELREMEL, INC.JSJ2022-12-30
00848838000461REMELREMEL, INC.JSJ2022-12-30