FastFlo 00711830
GUDID 10724995219205
FastFlo Injection Needle 23G, 4 mm is designed with a larger inner diameter to reduce needed injection force and increase flow rate during endoscopic procedures.
US Endoscopy
General-purpose endoscopic needle, single-use| Primary Device ID | 10724995219205 |
| NIH Device Record Key | cb3b7251-cd43-4037-bdbd-b7d349e8ea3d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FastFlo |
| Version Model Number | 00711830 |
| Catalog Number | 00711830 |
| Company DUNS | 627879687 |
| Company Name | US Endoscopy |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx |
Device Dimensions
| Outer Diameter | 2.4 Millimeter |
| Needle Gauge | 23 Gauge |
| Length | 230 Centimeter |
| Outer Diameter | 2.4 Millimeter |
| Needle Gauge | 23 Gauge |
| Length | 230 Centimeter |
| Outer Diameter | 2.4 Millimeter |
| Needle Gauge | 23 Gauge |
| Length | 230 Centimeter |
| Outer Diameter | 2.4 Millimeter |
| Needle Gauge | 23 Gauge |
| Length | 230 Centimeter |
| Outer Diameter | 2.4 Millimeter |
| Needle Gauge | 23 Gauge |
| Length | 230 Centimeter |
| Outer Diameter | 2.4 Millimeter |
| Needle Gauge | 23 Gauge |
| Length | 230 Centimeter |
| Outer Diameter | 2.4 Millimeter |
| Needle Gauge | 23 Gauge |
| Length | 230 Centimeter |
| Outer Diameter | 2.4 Millimeter |
| Needle Gauge | 23 Gauge |
| Length | 230 Centimeter |
| Outer Diameter | 2.4 Millimeter |
| Needle Gauge | 23 Gauge |
| Length | 230 Centimeter |
| Outer Diameter | 2.4 Millimeter |
| Needle Gauge | 23 Gauge |
| Length | 230 Centimeter |
| Outer Diameter | 2.4 Millimeter |
| Needle Gauge | 23 Gauge |
| Length | 230 Centimeter |
| Outer Diameter | 2.4 Millimeter |
| Needle Gauge | 23 Gauge |
| Length | 230 Centimeter |
| Outer Diameter | 2.4 Millimeter |
| Needle Gauge | 23 Gauge |
| Length | 230 Centimeter |
| Outer Diameter | 2.4 Millimeter |
| Needle Gauge | 23 Gauge |
| Length | 230 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radioactive sources |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radioactive sources |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radioactive sources |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radioactive sources |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radioactive sources |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radioactive sources |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radioactive sources |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radioactive sources |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radioactive sources |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radioactive sources |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radioactive sources |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radioactive sources |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radioactive sources |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from heat and radioactive sources |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00724995219208 [Primary] |
| GS1 | 10724995219205 [Package] Contains: 00724995219208 Package: Box [10 Units] In Commercial Distribution |
| GS1 | 50724995219203 [Package] Package: Case [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K212668
FDA Product Code
| FBK | endoscopic injection needle, gastroenterology-urology |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-17 |
| Device Publish Date | 2022-11-09 |
On-Brand Devices [FastFlo]
| 50724995219210 | FastFlo Injection Needle 23G, 4 mm is designed with a larger inner diameter to reduce needed inj |
| 10724995219205 | FastFlo Injection Needle 23G, 4 mm is designed with a larger inner diameter to reduce needed inj |
| 10724995219199 | FastFlo Injection Needle 25G, 6 mm is designed with a larger inner diameter to reduce needed inj |
| 10724995219182 | The FastFlo Injection Needle 25G, 4 mm is designed with a larger inner diameter to reduce needed |
Trademark Results [FastFlo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FASTFLO 76550969 3136208 Dead/Cancelled |
FIBERWEB SIMPSONVILLE, INC. 2003-09-22 |
 FASTFLO 75404638 not registered Dead/Abandoned |
Dimension One Spas, Inc. 1997-12-12 |
 FASTFLO 74614000 not registered Dead/Abandoned |
DowElanco 1994-12-20 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.