FDA UDI
In Commercial Distribution
🇺🇸 United States
5008X HDF Hemodialysis Blood Tubing Set with CLiC Blood Chamber
DI: 00840861102372
·
Model: 03-5100-7C
·
Fresenius Medical Care Renal Therapies Group, LLC
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- 5008X HDF Hemodialysis Blood Tubing Set with CLiC Blood Chamber
- Primary DI
- 00840861102372
- Version / Model
- 03-5100-7C
- Company Name
- Fresenius Medical Care Renal Therapies Group, LLC
- Labeler DUNS
- 079732391
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-08
- Public Version
- 1
- Public Version Date
- 2024-04-16
- Public Version Status
- New
- Public Device Record Key
- 9bdd936c-06af-4b76-bd0f-d65848de17ee
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 |
|---|---|---|---|---|
| KOC | Accessories, Blood Circuit, Hemodialysis | Gastroenterology, Urology | 876.5820 | 2 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | Gastroenterology, Urology | 876.5820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34999 | Haemodialysis blood tubing set, single-use | A collection of tubing segments and associated devices (e.g., connectors, clamps) intended to be used to transfer blood between a patient's vascular access device and a haemodialyser during haemodialysis; it is sometimes referred to as haemodialysis blood lines. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10840861102379 | GS1 | Case | 24 | In Commercial Distribution | |
| Primary | 00840861102372 | GS1 |
Customer Contacts
- Phone
- 1 (800) 323-5188
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231534 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature. Protect from moisture, freezing and excessive heat.