FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CPS DIRECT™
DI: 05414734218313
·
Model: SLII
·
ST. JUDE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CPS DIRECT™
- Primary DI
- 05414734218313
- Version / Model
- SLII
- Catalog Number
- DS2C017
- Company Name
- ST. JUDE MEDICAL, INC.
- Labeler DUNS
- 790268031
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-27
- Public Version
- 5
- Public Version Date
- 2019-06-07
- Public Version Status
- Update
- Public Device Record Key
- 1e83e5ff-76f0-49a0-a1c0-abb2a965440a
- Distribution End Date
- 2018-03-28
Device Description
Slittable Outer Guide Catheter
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| DQY | CATHETER, PERCUTANEOUS | Cardiovascular | 870.1250 | 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 | 05414734218313 | GS1 |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 9 | French | |
| Length | 54 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -5 – 50 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 23 – 122 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 23 – 122 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- -5 – 50 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dark, dry place. Keep away from sunlight.