CapnuVue 4733-7-0

GUDID 10607411971379

CapnoVue M1 Mask (Pedatric). Single patient use.

SALTER LABS

Carbon-dioxide-sampling nasal oxygen cannula
Primary Device ID10607411971379
NIH Device Record Key47bb2d9c-c8f4-4f00-9b46-411597c3b152
Commercial Distribution StatusIn Commercial Distribution
Brand NameCapnuVue
Version Model Number4733-7-0
Catalog Number4733-7-0
Company DUNS022721133
Company NameSALTER LABS
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)421-0024
Emailcustomercare@salterlabs.com
Phone+1(800)421-0024
Emailcustomercare@salterlabs.com
Phone+1(800)421-0024
Emailcustomercare@salterlabs.com
Phone+1(800)421-0024
Emailcustomercare@salterlabs.com
Phone+1(800)421-0024
Emailcustomercare@salterlabs.com
Phone+1(800)421-0024
Emailcustomercare@salterlabs.com
Phone+1(800)421-0024
Emailcustomercare@salterlabs.com
Phone+1(800)421-0024
Emailcustomercare@salterlabs.com
Phone+1(800)421-0024
Emailcustomercare@salterlabs.com
Phone+1(800)421-0024
Emailcustomercare@salterlabs.com
Phone+1(800)421-0024
Emailcustomercare@salterlabs.com
Phone+1(800)421-0024
Emailcustomercare@salterlabs.com
Phone+1(800)421-0024
Emailcustomercare@salterlabs.com
Phone+1(800)421-0024
Emailcustomercare@salterlabs.com
Phone+1(800)421-0024
Emailcustomercare@salterlabs.com

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *-20 C to 50 C
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *-20 C to 50 C
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *-20 C to 50 C
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *-20 C to 50 C
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *-20 C to 50 C
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *-20 C to 50 C
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *-20 C to 50 C
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *-20 C to 50 C
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *-20 C to 50 C
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *-20 C to 50 C
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *-20 C to 50 C
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *-20 C to 50 C
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *-20 C to 50 C
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *-20 C to 50 C
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *-20 C to 50 C

Device Identifiers

Device Issuing AgencyDevice ID
GS100607411971372 [Primary]
GS110607411971379 [Package]
Contains: 00607411971372
Package: [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Date2020-02-04
Device Publish Date2020-01-27

On-Brand Devices [CapnuVue]

10607411971416CapnoVue Scope O2/CO2 Mask with Luer style connector
10607411971409CapnoVue Scope O2/CO2 Mask with Luer style connector
10607411971379CapnoVue M1 Mask (Pedatric). Single patient use.
10607411971362CapnoVue M1 Mask (Adult). Single patient use.
10607411971355CapnoVue M1 Mask (Adult). With thread grip. Single patient use.
10607411971348CapnoVue M1 Mask (Adult). Single patient use.
10607411971331CapnoVue M1 Mask (Adult). Single patient use.
10607411971324CapnoVue M1 Mask (Infant). Single patient use.
10607411971317CapnoVue M1 Mask (Pediatric). Single patient use.
10607411971300CapnoVue M1 Mask (Adult) with thread grip. Single patient use.
10607411971294CapnoVue M1 Mask (Adult) with thread grip. Single patient use.
10607411971287CapnoVue M1 Mask (Adult). Single patient use.
10607411971270CapnoVue M1 Mask (Adult). Single patient use.

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