ChoiceMMed

Primary DI
06942820461002
Brand
ChoiceMMed
Company
Beijing Choice Electronic Technology Co., Ltd.
Model
M-50A
Device description
SpO2 Sensor
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DQAOximeter

Product Code Classifications

CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06942820461002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06942820461002069428204610026942820461002

GMDN Terms

TermDefinition
Pulse oximeter probe, reusableA photoelectric device applied externally to a body site, e.g., a fingertip, ear lobe, the bridge of nose, a toe, or the bridge of the foot of a paediatric or adult patient for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using light detection. The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector, are received by an oximeter to which this device is connected. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., electrocardiogram (ECG). This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
526882823
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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