ROSCOE MEDICAL

GUDID 00092237604007

INVALID RING, 16 MOLDED FOAM

COMPASS HEALTH BRANDS CORP.

Perineal/coccygeal cushion Perineal/coccygeal cushion Perineal/coccygeal cushion Perineal/coccygeal cushion Perineal/coccygeal cushion Perineal/coccygeal cushion Perineal/coccygeal cushion Perineal/coccygeal cushion Perineal/coccygeal cushion Perineal/coccygeal cushion Perineal/coccygeal cushion Perineal/coccygeal cushion Perineal/coccygeal cushion
Primary Device ID00092237604007
NIH Device Record Keye08b1f65-cb32-45e2-b230-8d5e99af60b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameROSCOE MEDICAL
Version Model NumberIR-16
Company DUNS827221698
Company NameCOMPASS HEALTH BRANDS CORP.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100092237604007 [Primary]
GS100092237604007 [Primary]
GS100092237604007 [Primary]
GS100092237604007 [Primary]
GS100092237604007 [Primary]
GS100092237604007 [Primary]
GS100092237604007 [Primary]
GS100092237604007 [Primary]
GS100092237604007 [Primary]
GS100092237604007 [Primary]
GS100092237604007 [Primary]
GS100092237604007 [Primary]
GS100092237604007 [Primary]

FDA Product Code

LRLCushion, Hemorrhoid
LRLCushion, Hemorrhoid
LRLCushion, Hemorrhoid
LRLCushion, Hemorrhoid
LRLCushion, Hemorrhoid
LRLCushion, Hemorrhoid
LRLCushion, Hemorrhoid
LRLCushion, Hemorrhoid
LRLCushion, Hemorrhoid
LRLCushion, Hemorrhoid
LRLCushion, Hemorrhoid
LRLCushion, Hemorrhoid
LRLCushion, Hemorrhoid

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-15
Device Publish Date2020-09-07

On-Brand Devices [ROSCOE MEDICAL]

30092237620831DreamEasy 2 Full Face CPAP Mask, Starter Kit
30092237620824DreamEasy 2 Full Face CPAP Mask, Large
30092237620817DreamEasy 2 Full Face CPAP Mask, Medium
30092237620800DreamEasy 2 Full Face CPAP Mask, Small
30092237620732Dinosaur Nebulizer Compressor with Reusable and Disposable Neb Kits and Carry Bag
30092237620725Bunny Nebulizer Compressor System with Reusable and Disposable Neb Kits and Carry Bag
00092237620663Dog Nebulizer Compressor with Carry Bag
00092237619834Heavy duty aspirator
0009223761982750 PSI Aerosol Compressor
00092237619810Pediatric Hippo Nebulizer Compressor
30092237619804Roscoe Rite-Neb 4 Nebulizer Compressor with Disposable Neb Kit
00092237619711ZZZ Mask Full Face Small w/ Headgear
00092237619704ZZZ Mask Full Face Medium with Headgear
00092237619698ZZZ Mask Full Face, Large w/ Headgear
000922376195756" Silicone Tubing
000922376195374" Silicone Tubing
00092237619506Silicone Tubing for ROS-COMP
00092237619490Silicone Tubing for Suction 4"
00092237616147Final Bacteria Filter
00092237616130Suction Filter 1/4-3/8
00092237616123Suction Filter, 1/4
00092237616116VA Final Bacteria Filter
00092237615430Newport Vent and LP10 Intake Filter
00092237614525Suction Filter
00092237614419Empty Humidifier Jar
00092237614358Intake Filter Silencer
00092237614341Compressor Intake Filter
50092237614209Roscoe Neb kit incl Supply
50092237614193Neb kit with Pediatric Mask
50092237614186Neb kit with Adult Mask
00092237613948Intake Bacteria Filter
60092237613926SierraNeb 2 Neb Compressor
00092237613870Pediatric Frog Nebulizer Compressor
00092237613863Pediatric Dog Nebulizer Compressor
00092237613856Dinosaur Nebulizer Compressor
00092237613849Bunny Nebulizer Compressor
30092237607054Replacement LAL Mattress
80092237605291Shadow Nasal Pillows Mask (XS/
90092237605045Compressor Intake Filter
80092237604874DreamEasy Nasal CPAP Mask Starter Kit
80092237604867DreamEasy Nasal Mask w/ HG,
80092237604850DreamEasy Nasal Mask w/ HG,
80092237604843DreamEasy Nasal Mask w/ HG,
80092237604836DreamEasy Full Face Mask w/
80092237604829DreamEasy Full Face Mask w/
80092237604812DreamEasy Full Face Mask with
10092237603816Collection Jar 800cc with Float Top
90092237603492Compressor intake filter
20092237603387Roscoe Portable Suction
20092237603370Roscoe Suction Machine

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