FDA.reportPublic FDA data

Advocate Blood Pressure Monitor Model SPBP-04 Upper Arm XL Cuff

Primary DI
00894046001530
Brand
Advocate Blood Pressure Monitor Model SPBP-04 Upper Arm XL Cuff
Company
DIABETIC SUPPLY OF SUNCOAST, INC.
Model
406XL
Catalog number
406XL
Device description
Advocate Blood Pressure Monitor Model SPBP-04 Upper Arm XL Cuff
Published
2016-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
K150430000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150430000Arm Blood Pressure Monitor, Wrist Blood Pressure MonitorFudakang Industrial Co., Ltd.2015-04-17DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05894046001535PackageGS124In Commercial Distribution
10894046001537PackageGS13In Commercial Distribution
20894046001534PackageGS124In Commercial Distribution
00894046001530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
05894046001535058940460015355894046001535
1089404600153710894046001537
2089404600153420894046001534
00894046001530008940460015308940460015300894046001530

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
1-866-373-2824skolta@dsosi.com
1-561-790-0107lhenry@pharmasupply.com

Regulatory Flags#

DUNS number
043081723
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00894046001578Advocate Redi- Code+ Test Strips for Blood Glucose 50 CountBMB002BMB0022016-08-19
00894046001875Advocate Redi-Code+ Test Strips for Blood Glucose 35 CountBMB002-35BMB002-352016-08-19
00894046001394Advocate Redi-Code+ Pharmacy Test Strips BMB002-PBMB002-P2016-08-19
00852982006491Advocate Redi-Code+ Test Strips for Blood Glucose 10 countBMB002-10BMB002-102018-03-27
00852982006415ADVOCATE Heating Pad International327-INTLJY65002020-07-10
00894046001141ADVOCATE HEATING PAD KING SIZE315JY61012017-03-10
00894046001554ADVOCATE HEATING PAD CLASSIC SIZE327JY61002017-03-10
00852982006354ADVOCATE ORAL & RECTAL THERMOMETER1451452017-02-06
00894046001042Advocate Non-Contact Infra-red thermometer1401402016-08-22
00894046001516Advocate Blood Pressure Monitor, Wrist, Model SPBP-02, Bilingual403-FG403-FG2016-08-22
00894046001400Advocate Arm BPM S/M CUFF406 S/M406 S/M2016-08-22
00894046001417Advocate Arm BPM L Cuff406L406L2016-08-22
00894046001509American Heart- Tech Non-Speaking Wrist BPMKD-735405-HT2016-08-22
00852982006408Advocate Blood Pressure Monitor Non-Speaking Wrist FT-B05WFT-B05W2017-04-17
00894046001097Advocate Lancets Twist Top 30 Gauge3082020-06-22
00894046001899Advocate Lancets Safety 21 Gauge 2.4mm6342020-06-22
00894046001905Advocate Lancets Safety 23 Gauge6352020-06-22
00894046001912Advocate Lancets Safety 28 Gauge6372020-06-22
00894046001929Advocate Lancets Safety 26 G 1.8 mm6362020-06-22
00852982006132Advocate Pen Needle 31G 6MM 6436432016-12-12

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