FDA UDI
In Commercial Distribution
🇺🇸 United States
Dry Bicarb Mixing System
DI: 00814963021459
·
Model: BCMIX100
·
ROCKWELL MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Dry Bicarb Mixing System
- Primary DI
- 00814963021459
- Version / Model
- BCMIX100
- Catalog Number
- BCMIX100
- Company Name
- ROCKWELL MEDICAL, INC.
- Labeler DUNS
- 933721433
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-19
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- d2a76b96-dd78-4137-9052-0a43bd355f88
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | Gastroenterology, Urology | 876.5820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36342 | Haemodialysis system fluid mixer | An electrically-powered integral unit of a haemodialysis system that mixes a concentrate and water to the dialysis solution (dialysate) and monitors the mixture. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00814963021459 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K022521 | 000 |