AccessGUDID - DEVICE: iNAP (04719878320184)

GUDID

Device Identifier (DI) Information

Brand Name: iNAP
Version or Model: 81000-07
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 81000-07
Company Name: SOMNICS, INC.

Primary DI Number: 04719878320184
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 657169335 *Terms of Use

Device Description: iNAP One sleep therapy system simple package (console and saliva container)

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	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?
65078	Intraoral negative-pressure sleep apnoea unit	An electrically-powered device intended for home management of obstructive sleep apnoea (OSA) by using low, negative air pressure in the mouth to pull the soft palate and tongue forward to increase the patency of the pharynx; this repositioning obstructs oral breathing while allowing nasal breathing. It consists of a control unit containing a pump and sensor(s), to detect and adjust air pressure within the oral cavity, connected to a specially designed mouthpiece; it may in addition include associated items (e.g., saliva container, absorbent pad). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OZR	Intraoral Pressure Gradient Device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K193460	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
Handling Environment Atmospheric Pressure: between 760 and 1060 millibar
Handling Environment Humidity: between 15 and 93 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 169c037e-0f4d-4c15-ae15-fe3420f696d2
Public Version Date: July 23, 2021
Public Version Number: 2
DI Record Publish Date: July 13, 2021

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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-833-766-6427
Email: service.us@somnics.com

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