FDA UDI
In Commercial Distribution
🇺🇸 United States
IMPROSAFE® Blood Collection Set
DI: 06974481830965
·
Model: 25G x 3/4” x 12”
·
Guangzhou Improve Medical Instruments Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
9
Pkg Device Count
1
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Basic Information
- Brand Name
- IMPROSAFE® Blood Collection Set
- Primary DI
- 06974481830965
- Version / Model
- 25G x 3/4” x 12”
- Company Name
- Guangzhou Improve Medical Instruments Co., Ltd.
- Labeler DUNS
- 554555378
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-20
- Public Version
- 1
- Public Version Date
- 2022-02-28
- Public Version Status
- New
- Public Device Record Key
- 16a41f0a-d495-4bcb-9fe5-d221685df679
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 |
|---|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35209 | Non-fixed blood collection needle | A sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood collection set for drawing blood from a patient; it does not include wings for fixation/placement (i.e., not a venous butterfly/scalp vein needle). It is intended to be connected to blood collection tubing and/or a blood collection Luer connector for transfer into a blood specimen receptacle. It may include a pre-attached blood collection tube spike and/or a safety cover; however, it does not include blood collection tubing or a tube holder (i.e., not a set). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16974481830962 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 06974481830965 | GS1 | ||||
| Package | 26974481830969 | GS1 | 100 | In Commercial Distribution | ||
| Package | 86974481830961 | GS1 | 20 | In Commercial Distribution | ||
| Package | 46974481830963 | GS1 | 20 | In Commercial Distribution | ||
| Package | 56974481830960 | GS1 | 10 | In Commercial Distribution | ||
| Package | 66974481830967 | GS1 | 4 | In Commercial Distribution | ||
| Package | 76974481830964 | GS1 | 12 | In Commercial Distribution | ||
| Package | 96974481830968 | GS1 | 4 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153388 | 000 |