AccessGUDID - DEVICE: FastFlo (00724995219215)

GUDID

Device Identifier (DI) Information

Brand Name: FastFlo
Version or Model: 00711831
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00711831
Company Name: US Endoscopy

Primary DI Number: 00724995219215
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 627879687 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FBK	endoscopic injection needle, gastroenterology-urology

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K212668	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 2.4 Millimeter
Needle Gauge: 23 Gauge
Length: 230 Centimeter

Device Record Status

Public Device Record Key: 1c8400c2-435e-4b13-ba38-3c0fa0ff53a5
Public Version Date: November 17, 2022
Public Version Number: 1
DI Record Publish Date: November 09, 2022