FDA.reportPublic FDA data

Acc U Rate

Primary DI
00850579006367
Brand
Acc U Rate
Company
HEALTH CONNECTOR LLC
Model
400B Blue
Catalog number
10430L-BLUE
Device description
Fingertip Pulse Oximeter
Published
2016-12-07
Public version status
Update
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850579006367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850579006367008505790063678505790063670850579006367

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter, battery-poweredA portable, battery-powered, photoelectric device intended for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically applied to the fingertip or around the wrist; it may be used by healthcare facilities, emergency services, or in the home.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8329398290orders@medshopandbeyond.com

Regulatory Flags#

DUNS number
030369084
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850579006015Acc U RateCMS 500DL Pink430J-PINK-O2016-09-23
00850579006022Acc U RateCMS 500DL Black430J-BLACK-O2016-09-23
00850579006039Acc U RateCMS 500DL Blue430J-BLUE-O2016-09-23
00850579006046Acc U RateCMS 500D Blue430J/DL-BLUE-O2016-09-23
00850579006053Acc U RateCMS 500D Black430J/DL-BLACK-O2016-09-23
00850579006060Acc U RateCMS 500D Pink430J/DL-PINK-O2016-09-23
00850579006077Acc U RateCMS 500D Purple430J/DL-V-O2016-09-23
00850579006107Acc U RateCMS 500DL Purple430J-V-O22016-09-23
00850579006176ZacurateCMS 500DL Black430J-BLACK-OZ2016-09-23
00850579006183ZacurateCMS 500DL Blue430J-BLUE-OZ2016-09-23
00850579006206Acc U Rate430P430P-W2016-09-23
00850579006305ZacurateCMS 500DL Pink430J-PINK-OZ22016-09-23
00850579006312ZacurateCMS 500DL Purple430J-V-OZ32016-09-23
00850579006329Acc U Rate430/DL430/DL-W2016-09-23
00850579006336ZacurateCMS 500DL Black430J-BLACK-OZCA2016-09-30
00850579006343ZacurateCMS 500DL Blue430J-BLUE-OZCA2016-09-30
00850579006374Zacurate400B Blue430L-BL-Z2016-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
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B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
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