Who else makes this device?

Name: 2L Buffer Bottle
Brand: 2L Buffer Bottle

Hematology › Cell and Tissue CultureSystem, Suspension, Cell Culture

2l Buffer Bottle

This bottle can be used for slowly medium refreshment of the e.g. Adherent Bag. And, the addition and removal of liquids to/from e.g. the Adherent Bag

Registry build 21.09.26

1manufacturer

1catalogue number

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code KJF
Manufacturer	City	Province	Registered as	Device types
Diatrust Medical Co., Ltd.	Nanjing	Jiangsu	Manufacturer	48

Record

Regulatory record for 2L Buffer Bottle
Listed by	Scinus Cell Expansion Netherlands B.V.
FDA product code	KJF
Device type	System, Suspension, Cell Culture
Device class	Class 1
Regulation	21 CFR 864.2240
Premarket notification	Exempt
Record published	2021-01-14

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Radiation Sterilization
Supplied sterile	Yes
Single use	Yes
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for 2L Buffer Bottle
Catalogue number	Size	Status
2LB-03-01		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
G-Rex	Wilson Wolf Manufacturing LLC	31
Corning	Corning Incorporated	17
Quantum®	Terumo BCT, Inc..	7
EXP-PAK	Charter Medical, LLC	5
1L Bottle	Scinus Cell Expansion Netherlands B.V.	1
2L MC Bottle	Scinus Cell Expansion Netherlands B.V.	1
Scinus Cell Expansion System	Scinus Cell Expansion Netherlands B.V.	1
Save-A-Tooth	Smarthealth, Inc.	1
Adherent Bag	Scinus Cell Expansion Netherlands B.V.	1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.