FDA.reportPublic FDA data

N/A

Primary DI
00607411401350
Brand
N/A
Company
SALTER LABS
Model
ZML-9640B-125
Catalog number
ZML-9640B-125
Device description
"GAS SAMPLE LINE, .047"" ID x 120"" Length PE/PVC Male/Female connector"
Published
2017-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K930957000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K930957000ZEFON GAS SAMPLING LINESZefon Medical Products1993-07-02CCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607411401357PackageGS1500In Commercial Distribution
00607411401350PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060741140135710607411401357
00607411401350006074114013506074114013500607411401350

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.

Contacts#

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

Regulatory Flags#

DUNS number
022721133
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10607411007146CannulaideCA100-0-25CA100-0-252016-09-24
10607411007153CannulaideCA101-0-25CA101-0-252016-09-24
10607411007160CannulaideCA102-0-25CA102-0-252016-09-24
10607411007177CannulaideCA103-0-25CA103-0-252016-09-24
10607411007184CannulaideCA104-0-25CA104-0-252016-09-24
00607411301681N/A4950-7-74950-7-72016-09-24
00607411301698N/A4950F-7-74950F-7-72016-09-24
00607411301711N/A4950F-7-04950F-7-02016-09-24
00607411301728N/A4950-10-104950-10-102016-09-24
00607411301735N/A4950-14-144950-14-142016-09-24
00607411301742N/A4950F-14-144950F-14-142016-09-24
00607411301759N/A4950F-10-104950F-10-102016-09-24
00607411401367N/A49SOFT-FTG-10-1049SOFT-FTG-10-102017-11-21
00607411945397N/A49SOFT-7-7-049SOFT-7-7-02017-07-28
00607411945755N/A4950FTG-7-74950FTG-7-72017-07-28
00607411945816N/A49SOFT-14-1449SOFT-14-142017-08-28
00607411945823N/A49SOFT-F-7-749SOFT-F-7-72017-08-28
00607411947155N/A49SOFT-FTG-7-749SOFT-FTG-7-72017-11-21
00607411919145N/A4950TG-7-74950TG-7-72017-05-12
00607411919169N/A4950TG-14-144950TG-14-142017-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.CCK2026-05-27