FDA UDI
In Commercial Distribution
🇺🇸 United States
10" Dialysis Tubing Extensions (Pair)
DI: 16641670000825
·
Model: 1.5
·
Cardiomed Supplies Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- 10" Dialysis Tubing Extensions (Pair)
- Primary DI
- 16641670000825
- Version / Model
- 1.5
- Catalog Number
- 17-088
- Company Name
- Cardiomed Supplies Inc
- Labeler DUNS
- 240623124
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-08
- Public Version
- 1
- Public Version Date
- 2020-04-16
- Public Version Status
- New
- Public Device Record Key
- 0a39fc30-5bf0-42e0-a0a5-604c9c73e180
Device Description
10" Dialysis Tubing Extensions (Pair) are shot lengths of hemodialysis blood tubing with a male swivel luer lock connector on the one end and female luer lock connector on the other. A small pinch clamp is also provided on each tube segment. Protective caps are secured to each end to prevent product contamination and maintain sterility when the sterile pouch is opened.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | 870.4210 | 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 | 36641670000836 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 16641670000825 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K833112 | 000 |