FDA.reportPublic FDA data

Nonin

Primary DI
00849686070941
Brand
Nonin
Company
NONIN MEDICAL, INC.
Model
SAL-T-CONN
Device description
T-Connector
Published
2016-09-07
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
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
K063752000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063752000LIFESENSE, MODEL LS1-9RNonin Medical, Inc.2007-05-04DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849686070941PackageGS11In Commercial Distribution
00833166000597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849686070941008496860709418496860709410849686070941
00833166000597008331660005978331660005970833166000597

GMDN Terms#

Term, Definition table
TermDefinition
Y-piece breathing circuit connector, single-useA connecting device shaped in the form of a "Y" and designed to connect compatible components [e.g., the tubing and face mask or an endotracheal (ET) tube] to create a breathing circuit. In order to function this device will be part of a breathing circuit and will typically connect the inspiratory and expiratory sides at the point of entry into the patient. It will typically be used during anaesthesia and/or ventilation and is typically made of light plastic. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
763 553 9968Regulatory@nonin.com

Regulatory Flags#

DUNS number
174959692
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00833166000597NoninSAL-T-CONN2016-09-07
00849686072068Nonin9840AAT2016-08-24
00849686072129NoninLS1R2016-08-24
00849686072181NoninLS1-9R2016-08-24
00849686072204NoninLS1R-9R2016-08-24
00849686072600NoninCapno SW2017-03-13
00849686074307Nonin98432016-08-24
00849686074482Nonin9840SA2016-08-24
00849686071092Nonin9840AAT2016-09-03
00849686072136NoninLS12016-08-24
00849686052367MODEL 3150, WRIST-OX2, BLE31502024-11-21
00849686051698HANDHELD PULSE OXIMETER8500, PULSE OXIMETER2024-09-17
00849686065855HANDHELD PULSE OXIMETER2500C, PULSE OXIMETER CHARGER2024-09-17
00849686066524Reusable Finger Clip Pulse Oximetry Sensors8000AA, FINGER CLIP SENSOR 1M2024-09-17
00849686070637RESUSABLE PULSE OXIMETRY SENSOR SYSTEM8100Q2, REUSABLE EAR CLIP SENSOR2024-09-17
00849686085976REUSABLE PULSE OXIMETRY SOFT SENSORS70276, MODEL 8000JFW ADULT FLEXW DISP2024-09-17
00833166000122PALMSAT HANDHELD OXIMETER2500,8000SM2024-09-10
00833166000139PALMSAT HANDHELD OXIMETER2500, 8000SM-32024-09-10
00833166000146PALMSAT HANDHELD OXIMETER2500, 8000SL2024-09-10
00833166004410RESUSABLE PULSE OXIMETRY SENSOR SYSTEMEMBLA 8000J 3M2024-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10612479282190McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282213McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282237McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282251McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282275McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282299McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282312McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
09555866301385DISPO-MEDDISPO-MED (MALAYSIA) SDN. BHD.CCK2026-04-02
10197344162550MEDLINEMEDLINE INDUSTRIES, INC.CCK2025-10-17