Veraseal 3 Full Face AAV Non Vented Mask, Small

GUDID 10814747021535

Disposable full face non vented mask with anti-asphyxiation valve for use in positive pressure ventilation.

SLEEPNET, CORP.

CPAP/BPAP face mask, single-use
Primary Device ID10814747021535
NIH Device Record Keyea392445-ca6b-4e82-8d6e-d7d0787a21eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameVeraseal 3 Full Face AAV Non Vented Mask, Small
Version Model Number50953
Company DUNS785635186
Company NameSLEEPNET, CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100814747021538 [Primary]
GS110814747021535 [Package]
Contains: 00814747021538
Package: Case [10 Units]
In Commercial Distribution

FDA Product Code

CBKVentilator, Continuous, Facility Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-12-13
Device Publish Date2019-05-03

Devices Manufactured by SLEEPNET, CORP.

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00814747024638 - MiniMe Pediatric Mask with Headgear, Size Large2025-05-14 Pediatric nasal vented mask for use in positive pressure ventilation.
00814747024645 - MiniMe Pediatric Ventilation Mask with Headgear, Size Small2025-05-14 Pediatric nasal non vented mask for use in positive pressure ventilation.
00814747024652 - MiniMe Pediatric Ventilation Mask with Headgear, Size Medium2025-05-14 Pediatric nasal non vented mask for use in positive pressure ventilation.
00814747024669 - MiniMe Pediatric Ventilation Mask with Headgear, Size Large2025-05-14 Pediatric nasal non vented mask for use in positive pressure ventilation.
10814747024598 - Veraseal 2 Full Face Vented Mask, Extra Large2025-02-19 Disposable full face vented mask for use in positive pressure ventilation.
10814747024413 - Novaplus Full Face Non Vented Mask, Large2025-02-13 Disposable full face non vented mask for use in positive pressure ventilation.

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