FDA UDI
In Commercial Distribution
🇺🇸 United States
ABLE CENTRAL VENOUS CATHETER
DI: 06938634463196
·
Model: Single Lumen 16G*10cm
·
Guangdong Baihe Medical Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- ABLE CENTRAL VENOUS CATHETER
- Primary DI
- 06938634463196
- Version / Model
- Single Lumen 16G*10cm
- Catalog Number
- FV-1523
- 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
- 7
- Public Version Date
- 2024-06-20
- Public Version Status
- Update
- Public Device Record Key
- 0e4a68c0-e45e-4967-9db7-f7503cb48874
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 |
|---|---|---|---|---|
| FOZ | Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days | General Hospital | 880.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61594 | Central venous catheterization kit, short-term | A collection of devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, 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 | 26938634463190 | GS1 | 40 | In Commercial Distribution | ||
| Package | 16938634463193 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 06938634463196 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K070451 | 000 |