FDA Device Intelligence
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Bag, Urine Collection, Leg, For External Use, Non-Sterile

FDA product code NNW · Class 1 · Gastroenterology, Urology

142
Registered devices
37
Adverse events
2
Recalls
0
510(k) clearances

Devices with this code

Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 8.5" — UROCARE PRODUCTS, INC.Urocare® Reusable Latex Leg Bag 26 oz. (800 mL.) — UROCARE PRODUCTS, INC.Medline — MEDLINE INDUSTRIES, INC.Urocare® Fabric Leg Strap with Velcro® Fasteners, Sport sml/MED 15" to 24" DIA — UROCARE PRODUCTS, INC.Coulmed — Coulmed Products Group LLCConveen Contour — Coloplast A/SUrocare® Gasket Ring, Small (Set of 10) — UROCARE PRODUCTS, INC.Urocare® Male Urinal System, Laced Closue, Medium — UROCARE PRODUCTS, INC.Create Biotech — CREATE BIOTECH CO., LTD.Urocare® Tubing Clear-Vinyl with Connector 0.31" x 18" — UROCARE PRODUCTS, INC.Urocare® Tubing Clear-Vinyl with Nozzle Adapter, Cap & Sterile 0.28" ID x 18" — UROCARE PRODUCTS, INC.Urocare® Male Urinal System, Laced Closue, Extra-Large — UROCARE PRODUCTS, INC.TIDIShield — TIDI PRODUCTS, LLCALLEN — HILL-ROM, INC.ALLEN — HILL-ROM, INC.Urocare® Standard Top Adapter — UROCARE PRODUCTS, INC.Urocare® Tubing White-Rubber with Connector 0.31" ID x 18" — UROCARE PRODUCTS, INC.Urocare® Catheter Connector, Large 0.38" OD x 3" — UROCARE PRODUCTS, INC.Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.) — UROCARE PRODUCTS, INC.Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.) — UROCARE PRODUCTS, INC.Bryton Corporation — TIDI PRODUCTS, LLCUrocare® Lower Fabric Leg Strap with Velcro® Fasteners, Small 7" ~ 13" DIA. — UROCARE PRODUCTS, INC.Urocare® Tubing Connector, Small 0.31" OD x 2.25" — UROCARE PRODUCTS, INC.Conveen — Coloplast A/S

Recent recalls

DateFirmReason
2016-02-24Purewick CorporationPureWick is recalling external catheter for women Wicks because the labeling did not contain the phrase "This product contains dry natural rubber" and/or errone
2014-09-29Coloplast Manufacturing US, LLCColoplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.