AccessGUDID - DEVICE: Provent Sleep Therapy (00868020000208)

GUDID

Device Identifier (DI) Information

Brand Name: Provent Sleep Therapy
Version or Model: CAT1105
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CAT1105
Company Name: PROVENT SLEEP THERAPY, LLC

Primary DI Number: 00868020000208
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080469780 *Terms of Use

Device Description: Provent 30 Night Standard Pack contains 30 Standard resistance Provent

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
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?
11260	Nasal dilator	A surgical instrument intended to dilate nasal structures/passages during ear/nose/throat (ENT) procedures. It typically consists of a slender and cylindrical body, hollow or solid, made of metal or plastic and available in a variety of sizes and flexibilities. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHP	Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K102404	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
Storage Environment Humidity: between 0 and 40 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Expiratory Resistance 3.0 >= x < 8.0 cm H2O at 50 mL/sec flow rate per nostril

Device Record Status

Public Device Record Key: 1174e15c-8b26-47db-b8e8-465bb831697a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 25, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 888-757-9355
Email: info@proventtherapy.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES