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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MON | SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES | Gastroenterology, Urology | 876.5820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32144 | Haemodialysis system dialyser holder | A device used together with certain types of a haemodialysis system that is used to hold dialysers in order to attach the blood lines from the dialyser to the system. The device is typically made of plastic or stainless steel. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 04046955348916 | GS1 | ||||
| Primary | 04046955348923 | GS1 |
Customer Contacts
- Phone
- +1(800)227-2862
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius