FDA UDI
In Commercial Distribution
🇺🇸 United States
Shifeng
DI: G001S30000
·
Model: S-3000
·
Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Shifeng
- Primary DI
- G001S30000
- Version / Model
- S-3000
- Company Name
- Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.
- Labeler DUNS
- 529534554
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-17
- Public Version
- 4
- Public Version Date
- 2023-02-20
- Public Version Status
- Update
- Public Device Record Key
- a5b7c425-8f28-4757-8db4-6e25c49ebf80
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 |
|---|---|---|---|---|
| FMF | Syringe, Piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35387 | Anaesthesia Luer syringe | A device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer (infuse) anaesthetic drugs. At the distal end of the barrel is a male Luer connector (typically a Luer-lock type) for the attachment of the female connector (hub) of a hypodermic needle, administration set or dental syringe cannula. It is typically made of plastic and silicone materials and may have anti-stick properties (internally precoated with compatible substances) that allow the plunger to move smoothly. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | G001S30001 | HIBCC | Box | 100 | In Commercial Distribution | |
| Primary | G001S30000 | HIBCC | ||||
| Package | G001S30002 | HIBCC | Case | 20 | In Commercial Distribution |