FDA.reportPublic FDA data

Diagnostix™

Primary DI
00634782093907
Brand
Diagnostix™
Company
AMERICAN DIAGNOSTIC CORP
Model
2100CN
Catalog number
2100CN
Device description
DIAGNOSTIX Pulse Oximeter,Fingertip, Adult, Canada only
Published
2017-11-30
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
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101577000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101577000MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIESBeijing Choice Electronic Technololgy Co., Ltd.2010-12-02DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00634782500221PackageGS110In Commercial Distribution
00634782595326PackageGS125Not in Commercial Distribution
00634782895327PackageGS110In Commercial Distribution
00634782093907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00634782500221006347825002216347825002210634782500221
00634782595326006347825953266347825953260634782595326
00634782895327006347828953276347828953270634782895327
00634782093907006347820939076347820939070634782093907

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeterAn electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature14 Degrees Fahrenheit104 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
1-800-232-2670info@adctoday.com

Regulatory Flags#

DUNS number
108999095
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00634782102524Diagnostix™805MTA805MTA2026-10-16
00634782102449Multikuf™731-MCC1UB731-MCC1UB2026-10-06
00634782101725Diagnostix™805M805M2026-03-30
00634782102357ADView® 2.69006BPC9006BPC2026-10-06
00634782102456Diagnostix™54310LUB54310LUB2026-10-06
00634782102517ADC8974MAD8974MAD2026-10-06
00634782096427Multikuf™731-MCC1731-MCC12020-08-29
00634782102159Diagnostix™805NWWA805NWWA2026-08-26
00634782102166Diagnostix™805NMWA805NMWA2026-08-26
00634782102173Diagnostix™805NDWA805NDWA2026-08-26
00634782102197Adcuff™885TAWA885TAWA2026-08-26
00634782102203Adcuff™885NWA885NWA2026-08-26
00634782102210Adcuff™886NWA886NWA2026-08-26
00634782101459Prosphyg™760-11ABCAA760-11ABCAA2026-08-25
00634782101633Diagnostix™2101CN2101CN2026-08-25
00634782101848Adscope®603BKAC603BKAC2026-08-25
00634782102098Proscope™664BKKM664BKKM2026-08-25
00634782102104Proscope™664YKM664YKM2026-08-25
00634782102111Proscope™665YKM665YKM2026-08-25
00634782102128Adsoft™660-08BK660-08BK2026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20884838115389Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
20884838115396Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
06946725572818APKAPK Technology Co.,Ltd.DQA2026-10-14
06946725572825APKAPK Technology Co.,Ltd.DQA2026-10-14
06946725572801APKAPK Technology Co.,Ltd.DQA2026-10-09
07290019919346OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
07290019919414OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
07290019919421OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
07290019919438OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDQA2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDQA2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDQA2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDQA2026-10-04
06946725547168APKAPK Technology Co.,Ltd.DQA2026-09-24
06946725571705APKAPK Technology Co.,Ltd.DQA2026-09-20
06946725571903APKAPK Technology Co.,Ltd.DQA2026-09-20
07290016714265SleepSenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-09-08
06946725538005APKAPK Technology Co.,Ltd.DQA2026-09-04
06946725548998APKAPK Technology Co.,Ltd.DQA2026-09-04
06946725572276APKAPK Technology Co.,Ltd.DQA2026-09-04
06944413835153Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
00634782101633Diagnostix™AMERICAN DIAGNOSTIC CORPDQA2026-08-25
06924054300647Medical GuardianSHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-21
06946725572221APKAPK Technology Co.,Ltd.DQA2026-08-21
06924054300913BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-18
06924054300920BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-18
06970404880000UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880017UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880024UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18