FDA.reportPublic FDA data

N/A

Primary DI
10607411950961
Brand
N/A
Company
SALTER LABS
Model
ZML-9450-1
Catalog number
ZML-9450-1
Device description
Gas Sampling Line .040" ID x 96" Length PVC
Published
2018-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
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
10607411950961PackageGS15In Commercial Distribution
00607411950964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060741195096110607411950961
00607411950964006074119509646074119509640607411950964

GMDN Terms#

Term, Definition table
TermDefinition
Carbon-dioxide-sampling nasal oxygen cannulaA non-sterile, 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.

Sterilization Methods#

Method table
Method

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
false
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
00607411000737N/A8900-148900-142016-09-24
00607411006814N/ASO-1343SO-13432016-09-24
00607411009297N/ASO-1666-0SO-1666-02016-09-24
00607411102738N/A7914-147914-142016-12-22
00607411300059N/ASO-388-0SO-388-02016-09-24
00607411700002N/A7100-07100-02016-09-24
00607411700040N/A7600-07600-02016-09-24
00607411700057N/A7900-07900-02016-09-24
00607411889349N/ASO-1818-0SO-1818-02016-09-24
00607411889912n/aSO-1840-0SO-1840-02016-11-30
00607411890031N/A8900-78900-72016-09-24
00607411890055N/A8900TG-78900TG-72016-09-24
00607411890062N/A8901-08901-02016-09-24
00607411890079N/A8902-78902-72016-09-24
00607411890116N/A8905-08905-02016-09-24
00607411890123N/A8906-78906-72016-09-24
00607411890147n/a8910-08910-02016-11-30
00607411890154N/A8911-78911-72016-09-24
00607411890253N/A8924-78924-72016-09-24
00607411890260N/A8924TG-78924TG-72016-09-24

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