Intelair Nasal Airway Support System ENR212613, NR212613-1, NR212613-3

GUDID 00842071113735

Airway Assembly, 13cm, Pouched

APPLIED MEDICAL TECHNOLOGY, INC.

Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling Nasal oxygen cannula, carbon-dioxide-sampling
Primary Device ID00842071113735
NIH Device Record Keycdf18b62-a5f8-4185-8c96-ad74aa6028d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntelair Nasal Airway Support System
Version Model NumberENR212613
Catalog NumberENR212613, NR212613-1, NR212613-3
Company DUNS038101861
Company NameAPPLIED MEDICAL TECHNOLOGY, INC.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net
Phone(440) 717-4000
Emailcs@appliedmedical.net

Device Dimensions

Length13 Centimeter
Length13 Centimeter
Length13 Centimeter
Length13 Centimeter
Length13 Centimeter
Length13 Centimeter
Length13 Centimeter
Length13 Centimeter
Length13 Centimeter
Length13 Centimeter
Length13 Centimeter
Length13 Centimeter
Length13 Centimeter
Length13 Centimeter
Length13 Centimeter
Length13 Centimeter
Length13 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100842071113674 [Primary]
GS100842071113735 [Package]
Contains: 00842071113674
Package: Box 1 (NR212613-1) [1 Units]
In Commercial Distribution
GS100842071113742 [Package]
Contains: 00842071113674
Package: Box 3 (NR212613-3) [3 Units]
In Commercial Distribution

FDA Product Code

CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-10
Device Publish Date2023-07-01

On-Brand Devices [Intelair Nasal Airway Support System]

00842071113759Airway Assembly, 14cm, Pouched
00842071113735Airway Assembly, 13cm, Pouched
00842071113711Airway Assembly, 12cm, Pouched
00842071113698Airway Assembly, 11cm, Pouched

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