FDA UDI
In Commercial Distribution
🇺🇸 United States
B.BRAUN
DI: 04046963686758
·
Model: 7102231
·
B.Braun Avitum AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- B.BRAUN
- Primary DI
- 04046963686758
- Version / Model
- 7102231
- Catalog Number
- 7102231
- Company Name
- B.Braun Avitum AG
- Labeler DUNS
- 343689704
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-08-09
- Public Version
- 4
- Public Version Date
- 2020-12-18
- Public Version Status
- Update
- Public Device Record Key
- f978e0fd-a3e6-46dc-942b-ab93d3af6491
Device Description
Option WAN BSL Dialog+ SW 9 (7102231)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OUG | Medical device data system | General Hospital | 880.6310 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58130 | Haemodialysis system, institutional | An assembly of mains electricity (AC-powered) devices intended to be used to perform patient haemodialysis, a treatment whereby extracorporeal blood is passed through a filter to allow for the removal of toxins and/or the replacement of electrolytes, by trained professionals in a healthcare facility. The system functions with dialysate solution and a haemodialysis dialyser (haemodialyzer) for the transfer of substances by diffusion, osmosis and ultrafiltration. It typically includes a pump and tubing to circulate blood through the haemodialysis dialyser, a solution mixer to prepare the dialysate, a monitor with system controls, and other dedicated components. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046963686758 | GS1 |
Customer Contacts
- Phone
- +1(800)848-2066
- [email protected]
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 70 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 35 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal