FastFlo 00711829

GUDID 10724995219199

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.

US Endoscopy

General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use General-purpose endoscopic needle, single-use

• Primary Device ID: 10724995219199
• NIH Device Record Key: 49282d15-4847-4ce7-a684-85e5a55e33f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FastFlo
• Version Model Number: 00711829
• Catalog Number: 00711829
• 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
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Device Dimensions

• Length: 230 Centimeter
• Needle Gauge: 25 Gauge
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Needle Gauge: 25 Gauge
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Needle Gauge: 25 Gauge
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Needle Gauge: 25 Gauge
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Needle Gauge: 25 Gauge
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Needle Gauge: 25 Gauge
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Needle Gauge: 25 Gauge
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Needle Gauge: 25 Gauge
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Needle Gauge: 25 Gauge
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Needle Gauge: 25 Gauge
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Needle Gauge: 25 Gauge
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Needle Gauge: 25 Gauge
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Needle Gauge: 25 Gauge
• Outer Diameter: 2.4 Millimeter
• Length: 230 Centimeter
• Needle Gauge: 25 Gauge
• Outer Diameter: 2.4 Millimeter

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Protect from heat and radioactive sources
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Protect from heat and radioactive sources
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Protect from heat and radioactive sources
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Protect from heat and radioactive sources
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Protect from heat and radioactive sources
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Protect from heat and radioactive sources
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Protect from heat and radioactive sources
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Protect from heat and radioactive sources
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Protect from heat and radioactive sources
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Protect from heat and radioactive sources
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Protect from heat and radioactive sources
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Protect from heat and radioactive sources
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Protect from heat and radioactive sources
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Protect from heat and radioactive sources
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995219192 [Primary]
GS1	10724995219199 [Package]; Contains: 00724995219192; Package: Box [10 Units]; In Commercial Distribution
GS1	50724995219197 [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