FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Diacap®
DI: 04039239090496
·
Model: 7107367
·
B.Braun Avitum AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
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Basic Information
- Brand Name
- Diacap®
- Primary DI
- 04039239090496
- Version / Model
- 7107367
- Catalog Number
- 7107367
- Company Name
- B.Braun Avitum AG
- Labeler DUNS
- 343689704
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2015-08-09
- Public Version
- 6
- Public Version Date
- 2024-06-03
- Public Version Status
- Update
- Public Device Record Key
- 9abc5d14-000b-4e0b-a4c9-b2ba26d8811f
- Distribution End Date
- 2024-05-30
Device Description
Diacap® Ultra Dialysis Fluid Filters
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
- 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 |
|---|---|---|---|---|
| FKQ | SYSTEM, DIALYSATE DELIVERY, CENTRAL MULTIPLE PATIENT | Gastroenterology, Urology | 876.5820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47739 | Haemodialysis system dialysate pyrogen filter | A sterile device designed to be used with a haemodialysis system for filtration of dialysate during haemodialysis to remove bacteria and endotoxins and produce purified dialysate for the procedure. It may perform secondary safety filtering to prepare on-line substitution solution that can be infused into the patient to compensate for loss of fluid volume resulting from haemodialysis. It typically consists of a plastic housing, containing a hollow fibre membrane, with appropriate connectors at either end. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04039239090496 | GS1 | ||||
| Unit of Use | 04039239090489 | GS1 |
Customer Contacts
- Phone
- +1(800)848-2066
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile, handle with care
- Type
- Special Storage Condition, Specify
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry