FDA.reportPublic FDA data

Clever Choice

Primary DI
10898302140121
Brand
Clever Choice
Company
SIMPLE DIAGNOSTICS INC
Model
SDI-1796 BPM
Catalog number
98302-0140-12
Device description
Automatic Blood Pressure Monitor with Wide Range Cuff. Arm testing site. Also measures heart rate. Displays Blood Pressure reading as well as a World Health Organization rating of Blood Pressure readings, to easily indicate to user whether their blood pressure is too high or too low, and gives the user an idea of by how much.
Published
2022-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190507000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190507000Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd.2019-09-16DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10898302140121PackageGS124In Commercial Distribution
00898302140124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089830214012110898302140121
00898302140124008983021401248983021401240898302140124

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-inflation electronic sphygmomanometer, portable, arm/wristAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
004135503
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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

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
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