FDA.reportPublic FDA data

Walgreens

Primary DI
14719872480010
Brand
Walgreens
Company
HEALTH & LIFE CO., LTD.
Model
WGNBPW-910
Device description
wrist type blood pressure monitor
Published
2016-06-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
K160336000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160336000Full Automatic (NIBP) Blood Pressure MonitorHealth & Life Co., Ltd.2016-03-29DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14719872480010PackageGS112In Commercial Distribution
04719872480013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471987248001014719872480010
04719872480013047198724800134719872480013

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure700 KiloPascal1060 KiloPascal
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
657836743
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
04719872489238Hello HeartHHBPA-CUFFXL2025-12-04
04719872483571HomedicsBPA-945B2025-06-10
04719872483496Hello HeartHHBPA-100BT2025-04-18
04719872483502Homedics1565256A-6SH/ BPA-960BTA-WT2025-03-27
04719872480013WalgreensWGNBPW-9102016-06-13
04719872480020WalgreensWGNBPW-9202016-06-13
04719872480167WRISTECH82-36492016-08-11
04719872480181WRISTECH ZB-3649 2016-08-17
04719872480204HoMedicsBPW-O2002018-06-22
04719872483014WalgreensWGNBPA-9402016-06-13
04719872483021WalgreensWGNBPA-9502016-06-13
04719872483038WalgreensWGNBPA-960BT2016-06-13
04719872483205WalgreensWGNBPA-9452017-10-30
04719872483229HoMedicsBPA-O2002018-06-22
04719872483236HoMedicsBPA-0652019-04-01
04719872483243PRESTIGEHM-30-OB2019-02-27
04719872483250 PRESTIGEHM-352019-02-27
04719872483267Prime AlertPA0012019-02-27
04719872483274HM01WMTBPA-240BT2021-08-02
04719872486022Clinical GuardHL1002016-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06953825911645N/AShenzhen Urion Technology Co., LtdDXN2026-07-24
06953825911652ANOVATORShenzhen Urion Technology Co., LtdDXN2026-07-24
06953825911669SPASTACISEShenzhen Urion Technology Co., LtdDXN2026-07-24
06932825306057CareSimpleGuangdong Transtek Medical Electronics Co.,LtdDXN2026-07-21
06932825306064CareSimpleGuangdong Transtek Medical Electronics Co.,LtdDXN2026-07-21
00073796318321WIDE-RANGE D-RING CUFFOmron Healthcare, Inc.DXN2026-07-20
00073796392437SMALL D-RING CUFFOmron Healthcare, Inc.DXN2026-07-20
00816042016516FORAFORA CARE INC.DXN2026-07-20
00898939002758FORAFORA CARE INC.DXN2026-07-20
06953825911515N/AShenzhen Urion Technology Co., LtdDXN2026-07-16
00850044118670iHealthiHealth Labs Inc.DXN2026-07-14
00850044118687iHealthiHealth Labs Inc.DXN2026-07-14
00850078377234iHealthiHealth Labs Inc.DXN2026-07-14
06953825911416N/AShenzhen Urion Technology Co., LtdDXN2026-07-13
00845717011556N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
00845717011563N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06972040112842N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06972040113481N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06972040114358N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06972040114365N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06972040117397N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
MHC18602130N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06953825911294N/AShenzhen Urion Technology Co., LtdDXN2026-07-09
06953825911300N/AShenzhen Urion Technology Co., LtdDXN2026-07-09
06953825911317AlphamedShenzhen Urion Technology Co., LtdDXN2026-07-09
06953825911355N/AShenzhen Urion Technology Co., LtdDXN2026-07-09
06953825911393N/AShenzhen Urion Technology Co., LtdDXN2026-07-09
04250413403578Cuff ABPMpro without ECGSOMNOmedics AGDXN2026-07-07
04250413403585Cuff ABPMpro without ECGSOMNOmedics AGDXN2026-07-07
04250413406456Cuff ABPMpro for right armSOMNOmedics AGDXN2026-07-07