FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Kurin Blood Collection Set, 23 Ga, Push Button Needle, BioMerieux
DI: 00851682007067
·
Model: M-21223
·
PATHWAY, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Kurin Blood Collection Set, 23 Ga, Push Button Needle, BioMerieux
- Primary DI
- 00851682007067
- Version / Model
- M-21223
- Company Name
- PATHWAY, LLC
- Labeler DUNS
- 080312381
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-13
- Public Version
- 5
- Public Version Date
- 2020-07-23
- Public Version Status
- Update
- Public Device Record Key
- 74f137fb-166e-4495-ab8b-5991a9fbbebe
- Distribution End Date
- 2018-07-23
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
- 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 |
|---|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58490 | Venous butterfly needle/set | An invasive, hollow, tubular, metal device intended to puncture a vein to collect blood and/or for transient (<24 hours) or short-term (<= 30 days) administration of intravenous (IV) fluids. It includes wings for fixation/placement and may include tubing and/or connectors; however, it does not include accessories to facilitate introduction (e.g., stylet). The device may also be referred to as butterfly needle or scalp vein needle. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20851682007061 | GS1 | 4 | Not in Commercial Distribution | 2018-07-23 | |
| Package | 10851682007064 | GS1 | 50 | Not in Commercial Distribution | 2018-07-23 | |
| Primary | 00851682007067 | GS1 |