FDA UDI
In Commercial Distribution
🇺🇸 United States
ZHUSHI
DI: 06941917805378
·
Model: 3mL 0.6mm(23G)×38mmTWLB Luer-lock
·
Shandong Zhushi Pharmaceutical Group Co., Ltd. First Office
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ZHUSHI
- Primary DI
- 06941917805378
- Version / Model
- 3mL 0.6mm(23G)×38mmTWLB Luer-lock
- Company Name
- Shandong Zhushi Pharmaceutical Group Co., Ltd. First Office
- Labeler DUNS
- 554551139
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-26
- Public Version
- 1
- Public Version Date
- 2023-01-03
- Public Version Status
- New
- Public Device Record Key
- ed33b4b5-e275-48e1-906a-da3ab4cbe1ee
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
- Yes
- 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 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63095 | General-purpose syringe/needle | A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a non-retractable needle is included, either attached or detached (usually capped for user protection). It is intended for various medical applications and is not dedicated to medication administration. The syringe is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06941917805378 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212033 | 000 |