FDA UDI
In Commercial Distribution
🇺🇸 United States
ZYNRELEF Replacement Vented Vial Spikes
DI: 00347426903059
·
Model: N/A
·
Heron Therapeutics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ZYNRELEF Replacement Vented Vial Spikes
- Primary DI
- 00347426903059
- Version / Model
- N/A
- Catalog Number
- N/A
- Company Name
- Heron Therapeutics, Inc.
- Labeler DUNS
- 102099843
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-15
- Public Version
- 1
- Public Version Date
- 2021-07-23
- Public Version Status
- New
- Public Device Record Key
- a269d808-4604-4ffc-9a7d-b71cf18da8ca
Device Description
Base package contains quantity of 5 vented vial spikes.
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 |
|---|---|---|---|---|
| FMF | Syringe, Piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60538 | Luer/Luer linear connector, single-use | A small, non-powered, noninvasive tubular, two-way/linear connector with a Luer connection (either lock or slip) at both ends intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing nor puncturing component. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00347426903059 | GS1 |