Syringe Kit - Stroke
- Primary DI
- 30816777026706
- Brand
- Syringe Kit - Stroke
- Company
- MICROVENTION INC.
- Model
- MVSK60
- Catalog number
- MVSK60
- Device description
- Syringe Kit - Stroke
- Published
- 2021-11-26
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| FMF | Syringe, piston |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| FMF | Syringe, Piston | General Hospital | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K994253 | 000 | VACLOK SYRINGE | Merit Medical Systems, Inc. | 2000-01-05 | FMF |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00816777025906 | Primary | GS1 | 0 | |
| 30816777026706 | Unit of Use | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| General-purpose syringe, single-use | A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
Contacts
| Phone | Email |
|---|
| +1(714) 247-8000 | customerservice@microvention.com |
Regulatory Flags
- DUNS number
- 003263105
- Device count
- 5
- DM exempt
- true
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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