FDA.reportPublic FDA data

N/A

Primary DI
00607411000263
Brand
N/A
Company
SALTER LABS
Model
4702F-7-0
Catalog number
4702F-7-0
Device description
Salter Labs™ Pediatric. EtCO2/O2 Nasal Divided Cannula, female luer style CO2 connector. Adaptor 22 mm (I.D.) x 6 mm (O.D.)
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151421000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151421000Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample LinesSalter Labs2016-03-10CCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607411000260PackageGS110In Commercial Distribution
20607411000267PackageGS125In Commercial Distribution
00607411000263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060741100026010607411000260
2060741100026720607411000267
00607411000263006074110002636074110002630607411000263

GMDN Terms#

Term, Definition table
TermDefinition
Nasal oxygen cannula, carbon-dioxide-samplingA semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs. It is available in one-, two-, or four-prong configurations. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
022721133
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00607411947124N/A49SOFT-TG-10-1049SOFT-TG-10-102026-07-28
00607411947131N/A49SOFT-TG-14-1449SOFT-TG-14-142026-07-28
00607411947162N/A49SOFT-F-14-1449SOFT-F-14-142026-07-28
00607411000270N/A4703F-7-74703F-7-72016-09-24
00607411400391N/A4700-7-74700-7-72016-09-24
00607411400407N/A4700F-7-74700F-7-72016-09-24
00607411400421N/A4701F-7-04701F-7-02016-09-24
00607411400438N/A4702-7-04702-7-02016-09-24
00607411400452N/A4703-7-74703-7-72016-09-24
00607411400476N/A4705-7-04705-7-02016-09-24
00607411400483N/A4705F-7-04705F-7-02016-09-24
00607411400506N/A4706-7-04706-7-02016-09-24
00607411400513N/A4706F-7-04706F-7-02016-09-24
00607411400520N/A4706FTG-7-04706FTG-7-02016-09-24
00607411400544N/A4707-7-74707-7-72016-09-24
00607411400551N/A4707F-7-74707F-7-72016-09-24
00607411400575N/A4707FTG-7-74707FTG-7-72016-09-24
00607411400643N/A4703FTG-7-74703FTG-7-72016-09-24
00607411400698N/A4704-7-74704-7-72016-09-24
00607411400704N/A4704F-7-74704F-7-72016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00607411947124N/ASALTER LABSCCK2026-07-28
00607411947131N/ASALTER LABSCCK2026-07-28
00607411947162N/ASALTER LABSCCK2026-07-28
04048675795124Sample Line 2,5mDrägerwerk AG & Co. KGaACCK2026-07-21
04048675723677Vista 300 Sidestream CO2 ModuleShanghai Draeger Medical Instrument Co.,Ltd.CCK2026-07-13
00607411919190Salter Labs® Nasal CannulaSALTER LABSCCK2026-06-10
00607411919213Salter Labs® Nasal CannulaSALTER LABSCCK2026-06-10
00607411919206MedTronic ETCo2 CannulaSALTER LABSCCK2026-06-09
10884521858077NellcorCovidien LPCCK2026-05-29
10884521858084NellcorCovidien LPCCK2026-05-29
10884521858091NellcorCovidien LPCCK2026-05-29
10884521858107NellcorCovidien LPCCK2026-05-29
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