FDA UDI
In Commercial Distribution
🇺🇸 United States
micsafe
DI: 06971911292522
·
Model: 1
·
Jiangsu Micsafe Medical Tehcnology Co.,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- micsafe
- Primary DI
- 06971911292522
- Version / Model
- 1
- Company Name
- Jiangsu Micsafe Medical Tehcnology Co.,LTD.
- Labeler DUNS
- 554400604
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-31
- Public Version
- 1
- Public Version Date
- 2023-06-08
- Public Version Status
- New
- Public Device Record Key
- 8d9377d8-3f97-4d92-b896-77986a49ff9f
Device Description
SAFETY BLOOD COLLECTION NEEDLE WITH HOLDER 21Gx1 1/2
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58284 | Blood collection tube holder/needle | A sterile, hand-held cylindrical device with a pre-attached needle designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor with a pre-attached blood collection needle at one end and into which the blood collection tube is inserted at the other end; this also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16971911292529 | GS1 | BOX | 100 | In Commercial Distribution | |
| Primary | 06971911292522 | GS1 | ||||
| Package | 26971911292526 | GS1 | CASE | 500 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212019 | 000 |