FDA UDI
In Commercial Distribution
🇺🇸 United States
FlexCath Advance™
DI: 00763000217136
·
Model: 4FC12
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- FlexCath Advance™
- Primary DI
- 00763000217136
- Version / Model
- 4FC12
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-02
- Public Version
- 2
- Public Version Date
- 2020-03-05
- Public Version Status
- Update
- Public Device Record Key
- 161fcf30-4749-4d35-a9b7-f98f50eee747
Device Description
SHEATH 4FC12 FLEXCATH ADVANCE 12F US
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
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DRA | CATHETER, STEERABLE | Cardiovascular | 870.1280 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36079 | Haemostasis valve | A noninvasive device designed as a conduit through which a small-diameter diagnostic/interventional device(s) can be introduced into or withdrawn from a patient's vasculature while preventing backflow of blood; it might in addition be intended for urinary applications. It is intended to be attached, typically via Luer-lock, to an invasively-placed catheter introducer (not included) and typically has a self-sealing lumen(s) [e.g., Touhy-Borst valve] and sideport for the introduction of solutions. It may include noninvasive guidewire accessories (e.g., guidewire introducer). It is not designed to be connected between tubing (i.e., not an in-line valve). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00763000217136 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183174 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 65.0 | Centimeter | |
| Device Size Text, specify | Catheter shaft size 12 Fr |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -31 – 136 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry
- Type
- Handling Environment Humidity
- Temperature Range
- – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit