FDA UDI
In Commercial Distribution
🇺🇸 United States
FastFlo
DI: 00724995219192
·
Model: 00711829
·
US Endoscopy
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- FastFlo
- Primary DI
- 00724995219192
- Version / Model
- 00711829
- Catalog Number
- 00711829
- Company Name
- US Endoscopy
- Labeler DUNS
- 627879687
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-09
- Public Version
- 1
- Public Version Date
- 2022-11-17
- Public Version Status
- New
- Public Device Record Key
- 49282d15-4847-4ce7-a684-85e5a55e33f1
Device Description
FastFlo Injection Needle 25G, 6 mm is designed with a larger inner diameter to reduce needed injection force and increase flow rate during endoscopic procedures.
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
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FBK | endoscopic injection needle, gastroenterology-urology | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38825 | General-purpose endoscopic needle, single-use | A flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10724995219199 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 00724995219192 | GS1 | ||||
| Package | 50724995219197 | GS1 | Case | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212668 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 230 | Centimeter | |
| Needle Gauge | 25 | Gauge | |
| Outer Diameter | 2.4 | Millimeter |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 80 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from heat and radioactive sources
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry