FDA.reportPublic FDA data

APK

Primary DI
00694672553881
Brand
APK
Company
APK Technology Co.,Ltd.
Model
MAS-2319
Device description
M-Tech Compatible Disposable Infant SpO2 Sensor
Published
2023-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082846000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082846000APK SPO2 PULSE OXIMETER SENSORAPK Technology Co., Ltd.2009-04-03DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00694672553881PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00694672553881006946725538816946725538810694672553881

GMDN Terms#

Term, Definition table
TermDefinition
Tissue saturation oximeter sensor, reprocessedA photoelectric device that is applied externally to a site on the body surface of a paediatric or adult patient for transcutaneous measurement the percent oxygen saturation of haemoglobin in a volume of tissue (StO2) to assess the amount of oxygen delivered to that tissue, typically during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. It is connected to a tissue saturation oximeter via a fibreoptic cable. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529691989
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
true
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
06946725572900APKS410S-0302026-10-26
06946725572924APKPH-9898031720312026-10-26
06946725572931APKSL-700-0008-882026-10-26
06946725572948APKDTG-MAXN2026-10-26
06946725516188APKI-A0424-SP101PUA0424-SP101PU2026-03-11
06946725516195APKI-A0424-SW101PUA0424-SW101PU2026-03-11
06946725516201APKI-A0424-SR101PUA0424-SR101PU2026-03-11
06946725516218APKI-A0424-SI101PUA0424-SI101PU2026-03-11
06946725516225APKI-A0424-SY101PUA0424-SY101PU2026-03-11
06946725516232APKI-A0424-SA203PVA0424-SA203PV2026-03-11
06946725516249APKI-A0424-SA203PUA0424-SA203PU2026-03-11
06946725516256APKI-A0424-SP203PVA0424-SP203PV2026-03-11
06946725516263APKI-A0424-SP203PUA0424-SP203PU2026-03-11
06946725516270APKI-A0424-SW203PUA0424-SW203PU2026-03-11
06946725516287APKI-A0424-SR203PUA0424-SR203PU2026-03-11
06946725516300APKI-A0424-SY203PUA0424-SY203PU2026-03-11
06946725516317APKI-A0412-SA108PVA0412-SA108PV2026-03-11
06946725516324APKI-A0412-SA108PUA0412-SA108PU2026-03-11
06946725516331APKI-A0412-SP108PVA0412-SP108PV2026-03-11
06946725516348APKI-A0412-SP108PUA0412-SP108PU2026-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725572900APKAPK Technology Co.,Ltd.DQA2026-10-26
06946725572948APKAPK Technology Co.,Ltd.DQA2026-10-26
06946725516188APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516195APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516201APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516218APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516225APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516232APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516249APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516256APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516263APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516270APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516287APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516300APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516317APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516324APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516331APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516348APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516355APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516362APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516379APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516386APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516393APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516409APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516416APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516423APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516430APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516447APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516454APKAPK Technology Co.,Ltd.DQA2026-03-11
06946725516461APKAPK Technology Co.,Ltd.DQA2026-03-11