FDA.reportPublic FDA data

N/A

Primary DI
10607411889001
Brand
N/A
Company
SALTER LABS
Model
M041622-0
Catalog number
M041622-0
Device description
Adult Oral/Nasal Pressure Monitoring & Gas Sampling Cannula with 7' (2.1 m) tubes with male/female connector for gas sampling and pressure monitoring.
Published
2016-12-16
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNRVENTILATORY EFFORT RECORDER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNRVentilatory Effort RecorderAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151874000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151874000BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/NasalSalter Labs2016-04-15MNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607411889001PackageGS125In Commercial Distribution
00607411889004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060741188900110607411889001
00607411889004006074118890046074118890040607411889004

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.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

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
00607411201509Salter Labs Adult, ETC02 Nasal Sampling Cannula, female luer style connecSO-165090122016-09-24
00607411001147AirLife1007-01007-0-102016-11-30
00607411001154AirLife1008-01008-0-102016-11-30
00607411001024AirLife1005-01005-0-252016-11-30
10607411001045AirLife1016-0-251016-0-252016-11-30
10607411891714AirLife1017-0-251017-0-252016-11-30
10607411001038AirLife1006-0-1001006-0-1002016-11-30
10607411891110AirLife1217-0-251217-0-252016-11-30
00607411001048AirLife1016-01016-02019-04-29
00607411919039Salter Labs® High Concentration partial rebreather131202026-06-10
00607411919077Salter Labs® Nasal Cannula133002026-06-10
00607411919091Salter Labs® Nasal Cannula133042026-06-10
00607411919121Salter Labs® Nasal Cannula133092026-06-10
00607411919190Salter Labs® Nasal Cannula133372026-06-10
00607411919213Salter Labs® Nasal Cannula133472026-06-10
00607411919268Salter Labs® Oxygen Tubing134092026-06-10
00607411919282Oxygen Tubing Swivel Connector134452026-06-10
00607411919336Salter Labs® Percent-O2-Lock® Mask138152026-06-10
00607411919343Salter Labs® Full Kit Nebulizer139502026-06-10
00607411919367Salter Labs® Full Kit Nebulizer Set139522026-06-10

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