FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Diacap®
DI: 04046964319983
·
Model: 7204101
·
B.Braun Avitum AG
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
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Basic Information
- Brand Name
- Diacap®
- Primary DI
- 04046964319983
- Version / Model
- 7204101
- Catalog Number
- 7204101
- Company Name
- B.Braun Avitum AG
- Labeler DUNS
- 343689704
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2015-08-09
- Public Version
- 5
- Public Version Date
- 2021-08-20
- Public Version Status
- Update
- Public Device Record Key
- 2d40dcf7-6ead-4a28-866c-6a4eef700205
- Distribution End Date
- 2019-02-09
Device Description
DIACAP HIPS 12 PS DIALYZER
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
- Yes
- 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 |
| FJI | DIALYZER, CAPILLARY, HOLLOW FIBER | Gastroenterology, Urology | 876.5820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47072 | Hollow-fibre haemodialysis dialyser, single-use | A filter that functions as an artificial kidney and typically used in a haemodialysis system to remove impurities/fluid from the blood of a patient. It typically consists of cylindrical containers with thousands of longitudinally arranged hollow-fibre capillary tubes (e.g., polymer, modified cellulose) through which the blood flows. The tube walls function as a semi-permeable membrane, permitting passage of larger molecules from the blood to the dialysate on the outside of the tubes for removal. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046964319983 | GS1 | ||||
| Unit of Use | 04039239089766 | GS1 |
Customer Contacts
- Phone
- +1(800)848-2066
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 30 Degrees Celsius