FDA UDI
Not in Commercial Distribution
🇺🇸 United States
QUICKPIN
DI: 08426314734561
·
Model: QUICKPIN
·
LABORATORIOS GRIFOLS SA
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- QUICKPIN
- Primary DI
- 08426314734561
- Version / Model
- QUICKPIN
- Company Name
- LABORATORIOS GRIFOLS SA
- Labeler DUNS
- 463719725
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-05
- Public Version
- 6
- Public Version Date
- 2024-01-08
- Public Version Status
- Update
- Public Device Record Key
- a5eae159-7c74-4c7f-8e48-842212c49665
- Distribution End Date
- 2024-01-05
Device Description
QUICKPIN is a luer-lock spike used in manual or automated pharmacy compounding for addition and/or extraction of IV substances from rubber stoppered containers including multi-dose vials.
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
- 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
- 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 |
|---|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60822 | Medication transfer needle, filtering/vented | A slender, rigid, sharp or blunt, dual-lumen tube intended to be attached to a syringe and typically used in the pharmacy to aspirate and transfer fluid medication from a vial/ampule to another container for medication preparation or other purposes. It is designed to puncture the vial septum, aspirate medication and simultaneously allow air into the vial to reduce back-pressure; it has an integral filter intended to prevent the ingress of airborne microbial contaminants. Typically, the proximal end is a Luer connector. The device is sometimes referred to as vent spike. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 38426314734562 | GS1 | Box | 4 | Not in Commercial Distribution | 2024-01-05 |
| Package | 28426314734565 | GS1 | box | 50 | Not in Commercial Distribution | 2024-01-05 |
| Primary | 08426314734561 | GS1 |