FDA.reportPublic FDA data

Roo Defender

Primary DI
00198715680164
Brand
Roo Defender
Company
Roo Healthcare Solutions, LLC
Model
RHSRD1000
Device description
Case of 10 boxes of 100 count boxes of non-sterile Roo Defender Catheter covers
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
00198715680164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198715680164001987156801641987156801640198715680164

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
00198715190205Roo DefenderRHSRD1002026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198715190205Roo 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