FDA.reportPublic FDA data

Urocare® Latex-Free Anti-Snoring Strap

Primary DI
00792293062000
Brand
Urocare® Latex-Free Anti-Snoring Strap
Company
UROCARE PRODUCTS, INC.
Model
6200
Catalog number
6200
Device description
STRAP, ANTI-SNORING, LATEX-FREE, BUTTONS, REUSABLEContains:1 Head Strap,1 Chin Strap,2 Chin Liners and1 Lip Strap.
Published
2018-05-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRKDevice, Anti-Snoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRKDevice, Anti-SnoringDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00792293062000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00792293062000007922930620007922930620000792293062000

GMDN Terms#

Term, Definition table
TermDefinition
Mandible-repositioning sleep-disordered breathing orthosisA removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight0.06Pound

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
070637129
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00792293041005Urocare® Reusable Urinary Drainage Bottle 2,000 mL.410041002018-04-11
00792293041012Urocare® Cap with Housing for Reusable Urinary Drainage Bottle410141012018-04-11
00792293041029Urocare® Hooks for Reusable Urinary Drainage Bottle410241022018-04-11
00792293060013Urocare® "High-Flow" Little Red Valve™ (Anti-Reflux Valve)600160012018-04-11
00792293060037Urocare® Top Adapter for Urinary Drainage Bottle600360032018-04-11
00792293060167Urocare® Tubing White-Rubber with Connector 0.31" ID x 18"601660162018-05-31
00792293060174Urocare® Tubing White-Rubber with Connector & Sterile 0.31" x 18"601760172018-05-31
00792293060181Urocare® Tubing White-Rubber with Connector and Clamp 0.31" x 18"601860182018-05-31
00792293060198Urocare® Tubing Clear-Vinyl with Connector 0.31" x 18"601960192018-05-31
00792293060617Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 60"606160612018-04-11
00792293060860Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 18"608660862018-05-31
00792293069993Urocare® Thumb Tube Clamp, Adjustable699969992018-04-11
00792293070005Urocare® Thumb Tube Clamp, Two-Position700070002018-04-11
00792293070036Urocare® Urinary & Ostomy Appliance Cleaning Brush 8" (20cm)700370032018-06-01
00792293702043Urolux® Urinary and Ostomy Appliance Cleanser & Deodorant, Trial 4 oz. (118 mL.)7002047002042018-06-01
00792293702166Urolux® Urinary & Ostomy Appliance Cleanser/Deodorant, Standard 16 oz. (473 mL.)7002167002162018-06-01
00792293041401Urocare® Reusable Urinary Drainage Bottle 128 oz. (4,000 mL.)414041402018-04-11
00792293060006Urocare® Gasket Ring, Large (Set of 10)600060002018-04-11
00792293060204Urocare® Tubing Clear-Vinyl with Connector and Sterile 0.31" x 18"602060202018-05-31
00792293060600Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 60"606060602018-04-11

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Primary DI, Brand, Company table
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00850077473241Individual EMA Straps(EMAST15B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473258Individual EMA Straps(EMAST16B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473265Individual EMA Straps(EMAST17B)EMA SLEEP INCORPORATEDLRK2026-08-14
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00850077473302Individual EMA Straps(EMAST21B)EMA SLEEP INCORPORATEDLRK2026-08-14
00850077473319Individual EMA Straps(EMAST13C)EMA SLEEP INCORPORATEDLRK2026-08-14