FDA UDI
In Commercial Distribution
🇺🇸 United States
BDS
DI: 06935550817010
·
Model: 21G×3/4‘’
·
Jiangsu Shenli Medical Production Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- BDS
- Primary DI
- 06935550817010
- Version / Model
- 21G×3/4‘’
- Company Name
- Jiangsu Shenli Medical Production Co.,Ltd.
- Labeler DUNS
- 420611311
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-26
- Public Version
- 1
- Public Version Date
- 2022-02-03
- Public Version Status
- New
- Public Device Record Key
- bdf4e0c1-de4a-44ba-a0d7-96d19c4bbb57
Device Description
Safety Butterfly Needle Set with Luer Adapter Blood Collection Needle Set with Safety Shield Type:21G×3/4‘’
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 |
|---|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58497 | Blood collection set, invasive | A collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16935550817017 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 06935550817010 | GS1 | ||||
| Package | 26935550817014 | GS1 | 12 | In Commercial Distribution |