FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable Hemodialysis Access Catheter Set
DI: 06938634470897
·
Model: Double Lumen 8.5F*16cm
·
Guangdong Baihe Medical Technology Co., Ltd.
Product Codes
1
GMDN Terms
2
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Disposable Hemodialysis Access Catheter Set
- Primary DI
- 06938634470897
- Version / Model
- Double Lumen 8.5F*16cm
- Catalog Number
- FR-2915
- Company Name
- Guangdong Baihe Medical Technology Co., Ltd.
- Labeler DUNS
- 547055364
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 5
- Public Version Date
- 2024-06-20
- Public Version Status
- Update
- Public Device Record Key
- 91ee4778-a0ef-41f2-84e7-ab1c9487f854
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
- 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 |
|---|---|---|---|---|
| MPB | Catheter, Hemodialysis, Non-Implanted | Gastroenterology, Urology | 876.5540 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60879 | Haemodialysis catheterization kit | A collection of sterile devices and materials intended to be used for short-term (< 30 days) venous access during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It includes a nonimplantable double-lumen haemodialysis catheter, device dedicated to catheter introduction/function (e.g., introducer needle, guidewire) and includes non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device. | No | Active |
| 61630 | Haemodialysis/central venous catheterization kit | A collection of sterile devices and materials intended to be used for short-term (< 30 days) venous access during haemodialysis, by: 1) conducting blood from a patient and returning it after extracorporeal circulation, primarily during haemodialysis, but may also be intended for haemoperfusion and/or apheresis; and 2) enabling central venous access for intravenous (IV) administration and/or invasive venous blood pressure monitoring. It includes a nonimplantable triple-lumen haemodialysis catheter, devices dedicated to catheter introduction/function (e.g., introducer needle, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 26938634470891 | GS1 | 40 | In Commercial Distribution | ||
| Package | 16938634470894 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 06938634470897 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K102833 | 000 |