FDA.reportPublic FDA data

Nonin Pulse Oximeter

Primary DI
D040200121321
Brand
Nonin Pulse Oximeter
Company
WHIP-MIX CORPORATION
Model
20012132
Catalog number
20012132
Device description
A small wrist-worn device indicated for use in measuring, displaying, and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients.
Published
2021-06-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102350000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102350000PULSE OXIMETERNonin Medical, Inc.2010-12-22DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D040200121321PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
006385173
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

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D0406020175Articulating paper/film60201602012020-08-24
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D04060004140Articulating paper/film60004600042020-08-17
D04060005144Articulating paper/film60005600052020-08-17
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