Device
Case of 10 boxes of 100 count boxes of non-sterile Roo Defender Catheter covers
Manufacturer
Roo Healthcare Solutions, LLC
Roo Healthcare Solutions, LLC
Model: RHSRD1000
DI: 00198715680164
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-05
Current Version: 2026-05-13
Description
Case of 10 boxes of 100 count boxes of non-sterile Roo Defender Catheter covers
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
231f680b-ddf2-4b4b-9870-a682ffcd34f3
Distribution Status:
In Commercial Distribution
DUNS Number:
079280466
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Device ID:
00198715680164
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 64863
Name: Medical device holding garment
Definition:
A 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.
FDA Product Codes
OAG
Garment, Storage, Peritoneal Dialysis Catheter