FDA UDI
In Commercial Distribution
🇺🇸 United States
Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 25cc IAB
DI: 10607567106632
·
Model: 0884-00-0019-12
·
DATASCOPE CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 25cc IAB
- Primary DI
- 10607567106632
- Version / Model
- 0884-00-0019-12
- Catalog Number
- 0884-00-0019-12
- Company Name
- DATASCOPE CORP.
- Labeler DUNS
- 001660786
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 5
- Public Version Date
- 2021-12-06
- Public Version Status
- Update
- Public Device Record Key
- a3954c72-ec5b-41df-b749-ad800eaef07f
Device Description
Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 25cc IAB
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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DSP | System, Balloon, Intra-Aortic And Control | Cardiovascular | 870.3535 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58865 | Vascular catheter introduction set, nonimplantable | A collection of sterile, 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 | 10607567106632 | GS1 |
Customer Contacts
- Phone
- 888-627-8383
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 7.5 | French |