Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.) 76181

GUDID 20792293761815

BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, THUMB CLAMP DRAIN VALVE, MEDIUM, 18 FL. OZ. (550 ML.) Uro-Safe® bags have the first ever, built-in, anti-reflux valve that is virtually self-cleaning and interference free... ensuring uninterrupted flow and problem free use. Because our anti-reflux valve is enclosed in a hard valve housing, it can't be held shut even when in sitting or reclining positions like other inferior products. Why settle for anything else? Uro-Safe® vinyl leg bags are for use with Foley® indwelling or male external catheters and urostomy drainage. Each Uro-Safe® bag is hand-tested for defect through each phase of manufacturing and packaged individually in a sterile, easy, peel-open pouch with two(2) “latex-free” leg straps. Features/Contains: Latex-Free, DEHP-Free, Anti-Reflux Valve Chamber, Clear Vinyl on Both Sides, "Latex-Free" Leg Straps with Buttons #60062 and Illustrated Application Instructions.

UROCARE PRODUCTS, INC.

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Primary Device ID	20792293761815
NIH Device Record Key	d5d25fb0-92ba-4787-85fc-c9e38b94733f
Commercial Distribution Status	In Commercial Distribution
Brand Name	Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.)
Version Model Number	76181
Catalog Number	76181
Company DUNS	070637129
Company Name	UROCARE PRODUCTS, INC.
Device Count	1
DM Exempt	true
Pre-market Exempt	true
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	false
OTC Over-The-Counter	true

Customer Support Contacts

Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM
Phone	909-621-6013
Email	CUST.SUPPORT@UROCARE.COM

Device Dimensions

Total Volume	550 Milliliter
Total Volume	550 Milliliter
Total Volume	550 Milliliter
Total Volume	550 Milliliter
Total Volume	550 Milliliter
Total Volume	550 Milliliter
Total Volume	550 Milliliter
Total Volume	550 Milliliter
Total Volume	550 Milliliter
Total Volume	550 Milliliter
Total Volume	550 Milliliter
Total Volume	550 Milliliter
Width	4.75 Inch
Depth	0.5 Inch
Height	14.38 Inch
Weight	0.13 Pound
Total Volume	18 Fluid Ounce
Total Volume	550 Milliliter
Width	4.75 Inch
Depth	0.5 Inch
Height	14.38 Inch
Weight	0.13 Pound
Total Volume	18 Fluid Ounce
Total Volume	550 Milliliter
Width	4.75 Inch
Depth	0.5 Inch
Height	14.38 Inch
Weight	0.13 Pound
Total Volume	18 Fluid Ounce
Total Volume	550 Milliliter
Width	4.75 Inch
Depth	0.5 Inch
Height	14.38 Inch
Weight	0.13 Pound
Total Volume	18 Fluid Ounce
Total Volume	550 Milliliter
Width	4.75 Inch
Depth	0.5 Inch
Height	14.38 Inch
Weight	0.13 Pound
Total Volume	18 Fluid Ounce
Total Volume	550 Milliliter
Width	4.75 Inch
Depth	0.5 Inch
Height	14.38 Inch
Weight	0.13 Pound
Total Volume	18 Fluid Ounce
Total Volume	550 Milliliter
Width	4.75 Inch
Depth	0.5 Inch
Height	14.38 Inch
Weight	0.13 Pound
Total Volume	18 Fluid Ounce
Total Volume	550 Milliliter
Width	4.75 Inch
Depth	0.5 Inch
Height	14.38 Inch
Weight	0.13 Pound
Total Volume	18 Fluid Ounce
Total Volume	550 Milliliter
Width	4.75 Inch
Depth	0.5 Inch
Height	14.38 Inch
Weight	0.13 Pound
Total Volume	18 Fluid Ounce
Total Volume	550 Milliliter
Width	4.75 Inch
Depth	0.5 Inch
Height	14.38 Inch
Weight	0.13 Pound
Total Volume	18 Fluid Ounce
Total Volume	550 Milliliter
Width	4.75 Inch
Depth	0.5 Inch
Height	14.38 Inch
Weight	0.13 Pound
Total Volume	18 Fluid Ounce
Total Volume	550 Milliliter
Width	4.75 Inch
Depth	0.5 Inch
Height	14.38 Inch
Weight	0.13 Pound
Total Volume	18 Fluid Ounce
Total Volume	550 Milliliter
Width	4.75 Inch
Depth	0.5 Inch
Height	14.38 Inch
Weight	0.13 Pound
Total Volume	18 Fluid Ounce
Total Volume	550 Milliliter
Width	4.75 Inch
Depth	0.5 Inch
Height	14.38 Inch
Weight	0.13 Pound
Total Volume	18 Fluid Ounce
Total Volume	550 Milliliter
Width	4.75 Inch
Depth	0.5 Inch
Height	14.38 Inch
Weight	0.13 Pound
Total Volume	18 Fluid Ounce
Total Volume	550 Milliliter
Width	4.75 Inch
Depth	0.5 Inch
Height	14.38 Inch
Weight	0.13 Pound
Total Volume	18 Fluid Ounce
Total Volume	550 Milliliter
Width	4.75 Inch
Depth	0.5 Inch
Height	14.38 Inch
Weight	0.13 Pound
Total Volume	18 Fluid Ounce
Total Volume	550 Milliliter
Width	4.75 Inch
Depth	0.5 Inch
Height	14.38 Inch
Weight	0.13 Pound
Total Volume	18 Fluid Ounce
Total Volume	550 Milliliter
Width	4.75 Inch
Depth	0.5 Inch
Height	14.38 Inch
Weight	0.13 Pound
Total Volume	18 Fluid Ounce
Total Volume	550 Milliliter
Width	4.75 Inch
Depth	0.5 Inch
Height	14.38 Inch
Weight	0.13 Pound
Total Volume	18 Fluid Ounce
Total Volume	550 Milliliter
Width	4.75 Inch
Depth	0.5 Inch
Height	14.38 Inch
Weight	0.13 Pound
Total Volume	18 Fluid Ounce
Total Volume	550 Milliliter
Width	4.75 Inch
Depth	0.5 Inch
Height	14.38 Inch
Weight	0.13 Pound
Total Volume	18 Fluid Ounce
Total Volume	550 Milliliter
Width	4.75 Inch
Depth	0.5 Inch
Height	14.38 Inch
Weight	0.13 Pound
Total Volume	18 Fluid Ounce
Total Volume	550 Milliliter
Width	4.75 Inch
Depth	0.5 Inch
Height	14.38 Inch
Weight	0.13 Pound
Total Volume	18 Fluid Ounce
Total Volume	550 Milliliter
Width	4.75 Inch
Depth	0.5 Inch
Height	14.38 Inch
Weight	0.13 Pound
Total Volume	18 Fluid Ounce
Total Volume	550 Milliliter
Width	4.75 Inch
Depth	0.5 Inch
Height	14.38 Inch
Weight	0.13 Pound
Total Volume	18 Fluid Ounce
Total Volume	550 Milliliter
Width	4.75 Inch
Depth	0.5 Inch
Height	14.38 Inch
Weight	0.13 Pound
Total Volume	18 Fluid Ounce
Total Volume	550 Milliliter
Width	4.75 Inch
Depth	0.5 Inch
Height	14.38 Inch
Weight	0.13 Pound
Total Volume	18 Fluid Ounce
Total Volume	550 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00792293761811 [Primary]
GS1	10792293761818 [Package] Contains: 00792293761811 Package: Case [12 Units] In Commercial Distribution
GS1	20792293761815 [Package] Contains: 00792293761811 Package: Case [168 Units] In Commercial Distribution

FDA Product Code

FAQ	Bag, Urine Collection, Leg, For External Use, Sterile

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2019-12-11
Device Publish Date	2018-04-10

On-Brand Devices [Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.)]

20792293771814	BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, THUMB CLAMP DRAIN VALVE, MEDIUM, 18 FL. O
20792293771807	BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, TWIST TYPE DRAIN VALVE, MEDIUM, 18 FL. OZ
20792293761815	BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, THUMB CLAMP DRAIN VALVE, MEDIUM, 18 FL. O
20792293761808	BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, TWIST TYPE DRAIN VALVE, MEDIUM, 18 FL. OZ
00792293791818	BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, THUMB CLAMP DRAIN VALVE, MEDIUM, 18 FL. O
00792293791801	BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, TWIST TYPE DRAIN VALVE, MEDIUM, 18 FL. OZ
00792293781819	BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, THUMB CLAMP DRAIN VALVE, MEDIUM, 18 FL. O
00792293781802	BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, TWIST TYPE DRAIN VALVE, MEDIUM, 18 FL. OZ