FDA UDI
In Commercial Distribution
🇺🇸 United States
Sunmed Haemostatic Valves
DI: 06947358546719
·
Model: 7F, Push-pull, Sideon Tubing and Stopcock, Insertion Tool, Torquer
·
Sunny Medical Device (Shenzhen) Co., Ltd.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sunmed Haemostatic Valves
- Primary DI
- 06947358546719
- Version / Model
- 7F, Push-pull, Sideon Tubing and Stopcock, Insertion Tool, Torquer
- Company Name
- Sunny Medical Device (Shenzhen) Co., Ltd.
- Labeler DUNS
- 529639795
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-06
- Public Version
- 1
- Public Version Date
- 2023-07-14
- Public Version Status
- New
- Public Device Record Key
- 434e6052-9345-4a72-a136-8aa6ef15bb4c
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
- No
- 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 |
| DQX | Wire, Guide, Catheter | Cardiovascular | 870.1330 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36079 | Haemostasis valve | A noninvasive device designed as a conduit through which a small-diameter diagnostic/interventional device(s) can be introduced into or withdrawn from a patient's vasculature while preventing backflow of blood; it might in addition be intended for urinary applications. It is intended to be attached, typically via Luer-lock, to an invasively-placed catheter introducer (not included) and typically has a self-sealing lumen(s) [e.g., Touhy-Borst valve] and sideport for the introduction of solutions. It may include noninvasive guidewire accessories (e.g., guidewire introducer). It is not designed to be connected between tubing (i.e., not an in-line valve). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06947358546719 | GS1 |