FDA.reportPublic FDA data

Clever Choice

Primary DI
00898302140179
Brand
Clever Choice
Company
SIMPLE DIAGNOSTICS INC
Model
SDCMS50D
Catalog number
BSX231
Device description
Clever Choice Premium Pulse Oximeter
Published
2017-04-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10898302140176PackageGS124In Commercial Distribution
00898302140179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089830214017610898302140176
00898302140179008983021401798983021401790898302140179

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeterAn electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.

Contacts#

Phone, Email table
PhoneEmail
1-877-342-2385customerservice@simplediagnostics.com

Regulatory Flags#

DUNS number
004135503
Device count
1
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00898302140230Comfort EZ Safety LancetCLES1002398302-0140-232025-11-25
00898302140438Clever Choice Comfort EZ"Insulin Syringe 27G 1cc 1/2"""98302-0140-432025-11-25
10898302140435Clever Choice Comfort EZInsulin Syringe 27G 1cc 1/2"98302-0140-432025-11-25
00898302140193Clever ChoiceFace Mask2022-01-04
00898302001890Clever ChoiceOrthopedic Back Brace2018-09-27
00898302001975Pharmacist ChoiceAlcohol Prep Pad 100ct62379-005-062016-08-01
00850002860382Clever Choice Peak Flow MeterSDI-PFM50002-0860-382019-11-04
00898302001456Clever ChoiceWhisper Aire Pediatric Child Nebulizer2017-01-02
00898302001449Clever ChoiceWhisper Aire Nebulizer2017-01-02
00898302140698Clever ChoiceSDI-BPMCA98302-0140-692023-02-14
00898302014180Clever ChoiceSDI-1486A BPM98302-0014-182023-02-13
00898302140124Clever ChoiceSDI-1796 BPM98302-0140-122022-06-07
00898302001005Simple DiagnosticsLAND98302-0001-002020-09-01
00898302001043Pharmacist ChoiceLAN3098302-0001-042020-09-01
00898302001609Pharmacist ChoiceLAN3198302-0001-602020-09-01
00898302140711Pharmacist ChoiceLAN3398302-0140-712020-09-02
00850002860603Pharmacist ChoiceULT3150002-0860-602022-10-19
00898302140209Comfort EZ Safety LancetCLES1002898302-0140-202022-10-19
10850002860600Pharmacist ChoiceULT3150002-0860-602022-10-19
20898302140203Comfort EZ Safety LancetCLES1002898302-0140-202022-10-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06944413835153Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
00634782101633Diagnostix™AMERICAN DIAGNOSTIC CORPDQA2026-08-25
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06946725572221APKAPK Technology Co.,Ltd.DQA2026-08-21
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06946725572092APKAPK Technology Co.,Ltd.DQA2026-08-14
06924054300906BERRYSHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-07-30
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