FDA.reportPublic FDA data

Reusable Sensor - RJ12

Primary DI
POX0207102
Brand
Reusable Sensor - RJ12
Company
MEDIAID INC
Model
POX020-710
Device description
SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The sensor uses optical means t
Published
2016-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K041964000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041964000MEDIAID REUSABLE FINGER CLIP SPO2 SENSORS AND DISPOSABLE NON-ADHESIVE SENSORS AND ADHESIVE SPO2 SENSORSMediaid, Inc.2004-09-14DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
POX0207102PackageHIBCC1In Commercial Distribution
B425POX0207102PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter, line-poweredA mains electricity (AC-powered) photoelectric device intended for the continuous 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 used bedside.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius45 Degrees Celsius
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
134990550
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B425CST02021212Adhesive Disposable SpO2 Sensors with Micro Foam Tape - AdultCST020-21212016-11-25
B425CST02021222Adhesive Disposable SpO2 Sensors with Micro Foam Tape - PediatricCST020-21222016-11-25
B425CST02021232Adhesive Disposable SpO2 Sensors with Micro Foam Tape - InfantCST020-21232016-11-25
B425CST02021242Adhesive Disposable SpO2 Sensors with Micro Foam Tape - NeonatalCST020-21242016-11-25
B425CST02022012Adhesive Disposable SpO2 Sensors with Micro Foam Tape - AdultCST020-22012016-11-25
B425CST02022022Adhesive Disposable SpO2 Sensors with Micro Foam Tape - PediatricCST020-22022016-11-25
B425CST02022032Adhesive Disposable SpO2 Sensors with Micro Foam Tape - InfantCST020-22032016-11-25
B425CST02022042Adhesive Disposable SpO2 Sensors with Micro Foam Tape - NeonatalCST020-22042016-11-25
B425CST02023022Adhesive Disposable SpO2 Sensors with Micro Foam Tape - PediatricCST020-23022016-11-25
B425CST02023032Adhesive Disposable SpO2 Sensors with Micro Foam Tape - InfantCST020-23032016-11-25
B425CST02023042Adhesive Disposable SpO2 Sensors with Micro Foam Tape - NeonatalCST020-23042016-11-25
B425CST02024012Adhesive Disposable SpO2 Sensors with Micro Foam Tape - AdultCST020-24012016-11-25
B425CST02024022Adhesive Disposable SpO2 Sensors with Micro Foam Tape - PediatricCST020-24022016-11-25
B425CST02024032Adhesive Disposable SpO2 Sensors with Micro Foam Tape - InfantCST020-24032016-11-25
B425CST02024042Adhesive Disposable SpO2 Sensors with Micro Foam Tape - NeonatalCST020-24042016-11-25
B425CST02026012Adhesive Disposable SpO2 Sensors with Micro Foam Tape - AdultCST020-26012016-11-25
B425CST02026022Adhesive Disposable SpO2 Sensors with Micro Foam Tape - PediatricCST020-26022016-11-25
B425CST02026032Adhesive Disposable SpO2 Sensors with Micro Foam Tape - InfantCST020-26032016-11-25
B425CST02026042Adhesive Disposable SpO2 Sensors with Micro Foam Tape - NeonatalCST020-26042016-11-25
B425CST02027022Adhesive Disposable SpO2 Sensors with Micro Foam Tape - PediatricCST020-27022016-11-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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