N/A - Pediatric. EtCO2/O2 Nasal Divided Cannula, female - SALTER LABS

Duns Number:022721133

Device Description: Pediatric. EtCO2/O2 Nasal Divided Cannula, female CO2 connector. Adaptor 22 mm (ID) x 6 mm Pediatric. EtCO2/O2 Nasal Divided Cannula, female CO2 connector. Adaptor 22 mm (ID) x 6 mm (OD)

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More Product Details

Catalog Number

47SOFT-PED-7-7

Brand Name

N/A

Version/Model Number

47SOFT-PED-7-7

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K151421,K151421

Product Code Details

Product Code

CCK

Product Code Name

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Device Record Status

Public Device Record Key

98b6462c-0cd3-4523-8242-b006c7b8ad69

Public Version Date

March 22, 2022

Public Version Number

4

DI Record Publish Date

October 26, 2017

Additional Identifiers

Package DI Number

10607411946711

Quantity per Package

25

Contains DI Package

00607411946714

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"SALTER LABS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 865
2 A medical device with a moderate to high risk that requires special controls. 1134