FDA.reportPublic FDA data

Qardio Pulse Oximeter

Primary DI
10854894005415
Brand
Qardio Pulse Oximeter
Company
QARDIO, INC.
Model
JPD-500F
Catalog number
JPD-500F
Published
2021-01-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170965000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170965000Fingertip Pulse OximeterShenzhen Jumper Medical Equipment Co., Ltd.2017-11-03DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10854894005415PackageGS1100In Commercial Distribution
00854894005418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085489400541510854894005415
00854894005418008548940054188548940054180854894005418

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
080029958
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
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
00854894005418Qardio Pulse OximeterJPD-500FJPD-500F2021-01-13
00854894005340QardioArm2A200A2002023-06-19
00854894005357QardioArm2A200-ILA200-IL2023-06-19
10854894005347QardioArm2A200A2002023-06-19
10854894005354QardioArm2A200-ILA200-IL2023-06-19
00854894005395Qardio Pro Cellular Blood Pressure MonitorBP100-4GBP100-4G2021-11-29
10854894005392Qardio Pro Cellular Blood Pressure MonitorBP100-4GBP100-4G2021-11-29
00854894005425Qardio Forehead thermometerTD-1261TD-12612021-01-08
10854894005422Qardio Forehead thermometerTD-1261TD-12612021-01-08
00854894005005QardioArmA100A1002016-09-24
00854894005012QardioArmA100A100-IRY2016-09-24
00854894005029QardioArmA100A100-IEB2016-09-24
00854894005036QardioArmA100A100-ILR2016-09-24
00854894005043QardioArmA100A100-IIR2016-09-24
00854894005050QardioArmA100A100-IMB2016-09-24
00854894005067QardioArmA100A100-IGO2016-09-24
00854894005074QardioArmA100A100-CRY2016-09-24
00854894005081QardioArmA100A100-CEB2016-09-24
00854894005104QardioArmA100A100-CAW2016-09-24
00854894005111QardioArmA100A100-CIR2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048675785910Masimo SpO2 Module for Vista 300/SShanghai Draeger Medical Instrument Co.,Ltd.DQA2026-07-13
00010939962218N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00093351041099N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013550N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013567N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113849N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113856N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06931973400563CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973400730CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973400785CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410326CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410333CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410340CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410364CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410371CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410388CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410395CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410401CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410418CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410425CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410432CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410449CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410456CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410647CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410678CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410685CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410692CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410715CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410722CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410739CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09