FDA UDI
In Commercial Distribution
🇺🇸 United States
CLCA - CLEANCART A
DI: 07332414127213
·
Model: 955850
·
GAMBRO AB
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CLCA - CLEANCART A
- Primary DI
- 07332414127213
- Version / Model
- 955850
- Catalog Number
- 955850
- Company Name
- GAMBRO AB
- Labeler DUNS
- 354021099
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-01
- Public Version
- 2
- Public Version Date
- 2024-01-22
- Public Version Status
- Update
- Public Device Record Key
- 6b850034-1213-4c51-96eb-b1945b11a391
Device Description
CleanCart A
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KDI | Dialyzer, high permeability with or without sealed dialysate system | Gastroenterology, Urology | 876.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58905 | Sodium carbonate haemodialysis system cleaning cartridge | A non-sterile cartridge containing anhydrous sodium carbonate designed to be connected to the fluid circuit of an institutional haemodialysis system for the in-line preparation of a sodium carbonate solution to clean the fluid pathways of the system (remove organic deposits, fats, proteins) in combination with a heat disinfection program. The solution is typically rinsed or flushed in a closed loop for a specified period. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 37332414127214 | GS1 | Case | 33 | In Commercial Distribution | |
| Primary | 07332414127213 | GS1 |
Customer Contacts
- Phone
- +1(800)933-0303
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232467 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 13 | Gram |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry. Do not store above 30°C.