FDA.report

Nonin

Primary DI
00833166009941
Brand
Nonin
Company
NONIN MEDICAL, INC.
Model
Sens DAC
Device description
3.5 MONO SENS DAC, 1V CAPNO,
Published
2016-09-23
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

Related Records

Product Codes

CodeName
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Product Code Classifications

CodeDeviceSpecialtyClass
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00833166009941PackageGS11In Commercial Distribution
00849686073485PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00833166009941008331660099418331660099410833166009941
00849686073485008496860734858496860734850849686073485

GMDN Terms

TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
174959692
Device count
1
DM exempt
false
Premarket exempt
true
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

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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
00833166009859FINGERTIP PULSE OXIMETER9590 BLUE, OXIMETER2024-09-10
00833166009866FINGERTIP PULSE OXIMETER9590 RED, OXIMETER 2024-09-10
00833166000054PALMSAT HANDHELD OXIMETER2500, 8001J2024-09-09
00849686050981WristOx2 Model 3150SC USB Comm Cable, Philips3150SC2021-04-05
00849686050998Soft Sensor Large WO2 Model 8000SL-WO28000SL-WO22021-04-05
00849686051001Soft Sensor Medium WO2 Model 8000SM-WO28000SM-WO22021-04-05
00849686051018Soft Sensor Small WO2 Model 8000SS-WO28000SS-WO22021-04-05
00849686051025WristOx2 Model 3150 with Bluetooth Low Energy31502021-04-05
00833166004113Nonin3150SC2016-09-03
00849686070972Nonin7500 Analog Cable2016-09-03

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