FDA UDI In Commercial Distribution 🇺🇸 United States

Streamline Dialyzer Holder

DI: 04046955348923 · Model: M8-2400A · B. BRAUN MEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
18

Basic Information

Brand Name
Streamline Dialyzer Holder
Primary DI
04046955348923
Version / Model
M8-2400A
Catalog Number
M8-2400A
Company Name
B. BRAUN MEDICAL INC.
Labeler DUNS
002397347
Distribution Status
In Commercial Distribution
Device Count in Pkg
18
Record Status
Published
Publish Date
2020-08-07
Public Version
1
Public Version Date
2020-08-17
Public Version Status
New
Public Device Record Key
0d61e4ee-26d5-4f0c-ad27-3757a0818c8f

Device Description

ANCILLARY-DIALYZER BRCKT ASS'Y FRESENIUS

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
MON SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES

GMDN Terms

Code Name
32144 Haemodialysis system dialyser holder

Identifiers

Type ID
Unit of Use 04046955348916
Primary 04046955348923

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
0 – 40 Degrees Celsius