FDA UDI
In Commercial Distribution
🇺🇸 United States
Manifold
DI: 06971162812081
·
Model: M-02
·
Tianck Medical Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Manifold
- Primary DI
- 06971162812081
- Version / Model
- M-02
- Catalog Number
- 121002
- Company Name
- Tianck Medical Co., Ltd.
- Labeler DUNS
- 418642903
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-06
- Public Version
- 2
- Public Version Date
- 2023-05-18
- Public Version Status
- Update
- Public Device Record Key
- 3a918ffa-d6b6-469a-ab81-03415f3180c1
Device Description
Right off 500PSI
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | Cardiovascular | 870.4290 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46979 | Double-lumen haemodialysis catheter, nonimplantable | A flexible, double-lumen tube intended to be used for short-term (< 30 days) central venous (jugular, subclavian vein) and/or femoral vein access, primarily 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 is intended for coaxial flow of blood and may be radiopaque; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06971162812081 | GS1 | ||||
| Package | 16971162812088 | GS1 | middle package | 25 | In Commercial Distribution | |
| Package | 26971162812085 | GS1 | outer package | 4 | In Commercial Distribution |