FDA UDI
In Commercial Distribution
🇺🇸 United States
IMPROSAFE® Blood Collection Set
DI: 06933395620437
·
Model: 27G x 2/5” x 12”
·
Guangzhou Improve Medical Instruments Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
8
Pkg Device Count
1
Basic Information
- Brand Name
- IMPROSAFE® Blood Collection Set
- Primary DI
- 06933395620437
- Version / Model
- 27G x 2/5” x 12”
- Company Name
- Guangzhou Improve Medical Instruments Co., Ltd.
- Labeler DUNS
- 530148444
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-23
- Public Version
- 6
- Public Version Date
- 2021-04-07
- Public Version Status
- Update
- Public Device Record Key
- acf0f18b-9efa-4030-bbaa-f79d669b6b70
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
- 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 | 76933395620436 | GS1 | 20 | In Commercial Distribution | ||
| Package | 26933395620431 | GS1 | 100 | In Commercial Distribution | ||
| Primary | 06933395620437 | GS1 | ||||
| Package | 66933395620439 | GS1 | 4 | In Commercial Distribution | ||
| Package | 16933395620434 | GS1 | 50 | In Commercial Distribution | ||
| Package | 56933395620432 | GS1 | 10 | In Commercial Distribution | ||
| Package | 46933395620435 | GS1 | 20 | In Commercial Distribution | ||
| Package | 86933395620433 | GS1 | 12 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153388 | 000 |