FDA UDI
In Commercial Distribution
🇺🇸 United States
Introducer Kit, 7F
DI: M20689841
·
Model: 8984
·
Vascular Solutions, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Introducer Kit, 7F
- Primary DI
- M20689841
- Version / Model
- 8984
- Company Name
- Vascular Solutions, Inc.
- Labeler DUNS
- 008999906
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-24
- Public Version
- 3
- Public Version Date
- 2024-03-20
- Public Version Status
- Update
- Public Device Record Key
- 0479c353-525e-41c7-aefa-0ce7d95cfcd4
Device Description
The Introducer Kit facilitates percutaneous entry of an intravascular device. Model 8983 contains 7F, 11cm introducer sheath with separate dilator and 20 puncture needle along with 40 cm guidewire.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| DYB | Introducer, Catheter | Cardiovascular | 870.1340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58865 | Vascular catheter introduction set, nonimplantable | A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M20689841 | HIBCC |
Customer Contacts
- Phone
- 888-240-6001
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Introducer Sheath Compatibility | 7 | French | |
| Length | 11 | Centimeter | |
| Needle Gauge | 20 | Gauge | |
| Guidewire Length | 40 | Centimeter |