CapnuVue 4733-7-0

GUDID 10607411971379

CapnoVue M1 Mask (Pedatric). Single patient use.

SALTER LABS

Carbon-dioxide-sampling nasal oxygen cannula

Primary Device ID	10607411971379
NIH Device Record Key	47bb2d9c-c8f4-4f00-9b46-411597c3b152
Commercial Distribution Status	In Commercial Distribution
Brand Name	CapnuVue
Version Model Number	4733-7-0
Catalog Number	4733-7-0
Company DUNS	022721133
Company Name	SALTER LABS
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *-20 C to 50 C
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *-20 C to 50 C
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *-20 C to 50 C
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *-20 C to 50 C
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *-20 C to 50 C
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *-20 C to 50 C
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *-20 C to 50 C
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *-20 C to 50 C
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *-20 C to 50 C
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *-20 C to 50 C
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *-20 C to 50 C
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *-20 C to 50 C
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *-20 C to 50 C
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *-20 C to 50 C
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *-20 C to 50 C

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607411971372 [Primary]
GS1	10607411971379 [Package] Contains: 00607411971372 Package: [50 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K151421

FDA Product Code

CCK	ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-02-04
Device Publish Date	2020-01-27

On-Brand Devices [CapnuVue]

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