FDA.reportPublic FDA data

Andnesfit Health

Primary DI
04897100310018
Brand
Andnesfit Health
Company
ANDESFIT LIMITED
Model
ADF-B05
Device description
Wireless Pulse Oximeter
Published
2021-03-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
PGJOximeter, Wellness

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PGJOximeter, WellnessCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04897100310018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04897100310018048971003100184897100310018

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

Regulatory Flags#

DUNS number
664101036
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04897100310025Andnesfit HealthADF-B062021-05-03
04897100310162Andnesfit HealthADF-MSA1002021-05-03
00146191010005AndesfitADF-MSA1002019-09-09
04897100310254Andesfit ADF-B612023-05-02
04897100310056Andnesfit HealthADF-B192022-02-08
04897100310117Andnesfit HealthADF-34A2022-02-08
04897100310131Andnesfit HealthADF-B38A2022-02-08
00146191200505Andnesfit HealthADF-B052019-12-11
00146191200604AndesfitADF-B062019-05-09
04897100310155Andnesfit HealthADF-B885T2021-08-18
04897100310070Andnesfit HealthADF-B272021-05-03
00146191203803AndesfitADF-B38A2019-03-15
00146191203407Andnesfit HealthADF-B34A2020-05-29
00146191201908AndesfitADF-B192019-03-15
00146191210221AndesfitADF-B102W2019-03-15
00146191202707Andnesfit HealthADF-B272019-10-14
00146191202776Andnesfit HealthADF-B27GTS2019-10-14
00146191288527Andnesfit HealthADF-B885T2019-10-14

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Primary DI, Brand, Company table
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06970392218724SEJOYJOYTECH HEALTHCARE CO.,LTDPGJ2026-03-27
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B635BIOKIT0100Biokit O2BIOTRICITY INCPGJ2025-09-24
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