AccessGUDID - DEVICE: Revive (00854389008009)

GUDID

Device Identifier (DI) Information

Brand Name: Revive
Version or Model: 0025
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0025
Company Name: RINOVUM SUBSIDIARY 2, LLC

Primary DI Number: 00854389008009
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081362926 *Terms of Use

Device Description: The Revive reusable bladder support is intended for temporary management of urinary leakage caused by stress urinary incontinence (SUI) in women, 18 years and older.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
59082	Urinary-incontinence vaginal insert, reusable	A non-sterile, device intended to be inserted into the vagina in order to relieve mixed or stress urinary incontinence in an adult female by providing urethral support when pressure is transferred from the abdomen to the pelvic floor area (e.g. upon coughing, laughing, sneezing, exertion). It is a non-absorbent device with a removal cord; an application kit (tube and push rod) is typically included. This is a reusable device - after appropriate cleaning - intended for single-patient use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HHW	Pessary, Vaginal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K183468	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3e1a4340-7ee8-4073-9dc2-288285337dc5
Public Version Date: April 12, 2019
Public Version Number: 1
DI Record Publish Date: April 04, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
20854389008027	6	10854389008020	In Commercial Distribution	Case
10854389008020	16	00854389008023	In Commercial Distribution	Case
00854389008023	2	00854389008009	In Commercial Distribution	Inner