FDA.reportPublic FDA data

Roo Defender

Primary DI
00198715190205
Brand
Roo Defender
Company
Roo Healthcare Solutions, LLC
Model
RHSRD100
Device description
100 Count box of the Roo Defender Non Sterile Catheter Cover
Published
2026-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
OAGGarment, Storage, Peritoneal Dialysis Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OAGGarment, Storage, Peritoneal Dialysis CatheterPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198715190205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198715190205001987151902051987151902050198715190205

GMDN Terms#

Term, Definition table
TermDefinition
Medical device holding garmentA non-powered device in the form of a garment (e.g., vest, shirt, pants) specifically designed to hold one or more independent medical device(s) [e.g., infusion pump, medicine cassette], connected to the body via tubes or leads, close to the body to minimize risk of detachment/displacement during daily movement and sleep. It is typically made of textile materials with pockets for the medical device(s), holes for the tubing, and may be secured with a zip fastener and/or Velcro. This is a single-patient reusable device.

Regulatory Flags#

DUNS number
079280466
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198715680164Roo DefenderRHSRD10002026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198715680164Roo DefenderRoo Healthcare Solutions, LLCOAG2026-05-05
05391537090080Mobility+ Enteral Feeding Device Bag PurpleROCKFIELD MEDICAL DEVICES LIMITEDOAG2024-07-03
05391537090097Mobility+ Enteral Feeding Device Bag BlackROCKFIELD MEDICAL DEVICES LIMITEDOAG2024-07-03
05391537090103Mobility+ Enteral Feeding Device Bag PurpleROCKFIELD MEDICAL DEVICES LIMITEDOAG2024-07-03
05391537090110Mobility+ Enteral Feeding Device Bag BlackROCKFIELD MEDICAL DEVICES LIMITEDOAG2024-07-03
00613994558572NAMEDTRONIC, INC.OAG2015-12-02
00613994558589NAMEDTRONIC, INC.OAG2015-12-02
00885074244242NAMEDTRONIC, INC.OAG2015-11-18