FDA.reportPublic FDA data

1L Bottle

Primary DI
08720299213623
Brand
1L Bottle
Company
Scinus Cell Expansion Netherlands B.V.
Model
1LB-02-01
Device description
This bottle can be used for the addition and removal of liquids to/from e.g. the Adherent Bag. (single-use)
Published
2021-01-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KJFSystem, Suspension, Cell Culture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KJFSystem, Suspension, Cell CultureHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08720299213623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720299213623087202992136238720299213623

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory liquid dispenser, manualA manual laboratory device designed to dispense fluid from a stock reservoir (e.g., a bottle or other container). The user determines the intended volume, typically up to 100 ml, by operating a manual pump. This device may be hand-held, or fitted to a bottle or alternative reservoir.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
493047487
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08720299213616Adherent BagADH-01-012020-12-09
087202992136302L Buffer Bottle2LB-03-012021-01-14
087202992136472L MC Bottle2LM-04-012021-01-14
08720299213609Scinus Cell Expansion SystemVCL31230012020-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850019717471G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2026-03-19
00850019717518G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2026-03-19
00850019717648G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2026-03-19
00850019717488G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2026-03-19
00850019717525G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2026-03-19
00850019717655G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2026-03-19
00850019717624G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2025-06-09
00850019717631G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2025-06-09
00850019717563G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2024-03-08
00850019717570G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2024-03-08
00850019717600G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2024-02-14
00850019717617G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2024-02-14
00850019717587G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2024-02-13
00850019717495G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2023-06-22
00850019717532G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2023-06-22
00850019717501G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2023-06-22
00850019717549G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2023-06-22
00854498007986Save-A-ToothSmarthealth, Inc.KJF2023-04-03
00850019717457G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2023-02-20
00850019717464G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2023-02-20
00850019717556G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2023-02-09
00850019717419G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-11-16
00850019717426G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-11-16
00850019717174G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-11-14
00850019717181G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-11-14
00850019717280G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-11-03
00850019717297G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-11-03
00850019717150G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-10-12
00850019717396G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-10-12
00850019717167G-RexWILSON WOLF MANUFACTURING CORPORATIONKJF2022-10-12