FDA.report

Astrapulse Pulse Oximeter

Primary DI
B279S296000
Brand
Astrapulse Pulse Oximeter
Company
S D I DIAGNOSTICS INC
Model
FT
Catalog number
29-6000
Device description
Astrapulse FT Pulse Oximeter
Published
2016-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DQAOximeter

Product Code Classifications

CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B279S296000PrimaryHIBCC0

GMDN Terms

TermDefinition
Pulse oximeter probe, single-useA 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). The is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
037690120
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

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B279F063908001PulmoguardVF0639-0802023-08-22
B279F06090501PulmoguardVF0609-0502022-12-06
B279S2931090501PulmoguardV29-3109-0502022-12-06
B279F06070501Astraguard Air F0607-0502022-06-20
B279F06071002Astraguard Air F0607-1002022-06-20
B279S29310705001Astraguard Air 29-3107-0502022-06-20
B279S2931071002Astraguard Air 29-3107-1002022-06-20
B279F06060501Pulmoguard CF0606-0502020-05-13
B279F06061002Pulmoguard CF0606-1002020-05-13
B279S2931060501Pulmoguard C29-3106-0502020-05-13
B279S2931061002Pulmoguard C29-3106-1002020-05-13

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