AccessGUDID - DEVICE: FItz-All® Fabric Leg Strap Kit with Velcro® Fasteners, Large (Set of 2) (00792293063700)

GUDID

Device Identifier (DI) Information

Brand Name: FItz-All® Fabric Leg Strap Kit with Velcro® Fasteners, Large (Set of 2)
Version or Model: 6370
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6370
Company Name: UROCARE PRODUCTS, INC.

Primary DI Number: 00792293063700
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070637129 *Terms of Use

Device Description: STRAP KIT, FABRIC, LEG BAG, LATEX-FREE, VELCRO FASTENERS, LARGE, REUSABLE Fits most vinyl disposable urinary leg bags and offers a vast improvement in comfort over the standard latex leg straps packaged with most vinyl leg bags. A special elasticated-loop material distributes pressure evenly along the length of the strap reducing the risk of bruising, pressure sores, pulled hair, circulation restriction and burns caused by rubber/latex straps. Long strap ties can be easily grasped and slipped through the eyelets of most all vinyl disposable leg bags. The self-gripping fasteners can engage anywhere along the length of the strap making the strap fully adjustable to individual requirements. A special blend of elastic and cotton makes them durable and allows them to be hand or machine washed. Set Contains: 1 Upper leg strap #6356, 1 Lower leg strap #6358 and Illustrated Use and Care Instructions. * BAGS MUST HAVE EYELETS FOR STRAP TIES TO PASS THROUGH

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
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?
58924	Open-ended wearable urine collection bag, non-sterile	A non-sterile flexible plastic pouch designed to connect to a urinary catheter, a urinary condom catheter, or a urostomy bag, and to be strapped to the leg of a patient to collect discharged urine; it is designed with an opening for urine drainage. Also known as a leg bag, it is worn on the body to facilitate patient mobility. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Weight: 0.12 Pound
Device Size Text, specify: Small: 2" (5cm) Wide, Fits: 13" ~ 20" DIA. (33cm x 50cm Ø), Large: 2" (5cm) Wide, Fits: 21" ~ 30" DIA. (53cm x 76cm Ø)
Device Size Text, specify: Can hold up to a 32 fl. oz. (1,000 mL.) leg bag

Device Record Status

Public Device Record Key: 1845a70e-7572-4e0f-83ae-ce9cbde2e5fc
Public Version Date: July 06, 2018
Public Version Number: 2
DI Record Publish Date: May 29, 2018