FDA.reportPublic FDA data

PharmaSmart International, Inc

Primary DI
00861706000141
Brand
PharmaSmart International, Inc
Company
PHARMA-SMART INTERNATIONAL, INC.
Model
PS1000LED
Published
2016-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSKComputer, Blood-Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSKComputer, Blood-PressureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K811148000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K811148000VITA-STAT MODEL 9000-SViat-Stat1981-06-30DSK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00861706000141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861706000141008617060001418617060001410861706000141

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-inflation electronic sphygmomanometer, non-portableAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm-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 not designed to be portable and is typically used bedside.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-781-0323csa@pharmasmart.com

Regulatory Flags#

DUNS number
078518633
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00861706000103PharmaSmart International, IncSmart Card2017-06-14
00861706000110PharmaSmart International, Inc.PS10002016-09-07
00861706000127PharmaSmart International, Inc.PS20002016-09-07

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