FDA UDI
In Commercial Distribution
🇺🇸 United States
FlowGate2
DI: 00815742004953
·
Model: 90495
·
Stryker Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FlowGate2
- Primary DI
- 00815742004953
- Version / Model
- 90495
- Catalog Number
- 90495
- Company Name
- Stryker Corporation
- Labeler DUNS
- 042405446
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 5
- Public Version Date
- 2023-12-04
- Public Version Status
- Update
- Public Device Record Key
- a38854b4-e373-4e06-bf3b-4949d12ff925
Device Description
Balloon 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
- 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 |
|---|---|---|---|---|
| DQY | CATHETER, PERCUTANEOUS | Cardiovascular | 870.1250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32584 | Intravascular occluding balloon catheter, image-guided | A non-powered flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and intracranial vasculature occlusion, emergency control of haemorrhage, to treat aneurysms, chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design for balloon inflation, introduction over a guidewire, infusion of contrast medium, or delivery of a smaller catheter or embolic agents; some types have graduated markings to assist insertion. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815742004953 | GS1 |
Customer Contacts
- Phone
- +1(855)916-3876
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153729 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 95.0 | Centimeter | |
| Catheter Gauge | 8.0 | French |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in cool, dry, dark place.