FDA.reportPublic FDA data

BodyMed

Primary DI
20815802014452
Brand
BodyMed
Company
BOXOUT, LLC
Model
ZZABP01
Catalog number
ZZABP01
Device description
BODYMED UPPER ARM BLOOD PRESSURE MONITOR WITH UNIVERSAL CUFF, DIGITAL, 22CM-52CM
Published
2016-09-05
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

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
K131558000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131558000PG-800B SERIES, INCLUDING PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6Shenzhen Pango Electronic Co., Ltd.2013-08-30DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815802014455PackageGS11In Commercial Distribution
20815802014452PackageGS118In Commercial Distribution
00815802014458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081580201445510815802014455
2081580201445220815802014452
00815802014458008158020144588158020144580815802014458

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, blood pressure, noninvasiveA small unit dedicated to the measurement of noninvasive blood pressure (indirect method) obtained through a standard sphygmomanometer cuff placed on the arm or leg. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the blood pressure parameter/information measured and provided by this module.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-528-2152info@bodysportproducts.com

Regulatory Flags#

DUNS number
066689993
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
00815991024405BodyMedBDMNEBCOM2022-07-01
00815991024412BodyMedBDMNEBDOG2022-07-01
00815991025167BodyMedBDMNEBCOMREU2025-07-17
00815991024047BodyMedBDMNTRGVMEDBDMNTRGVMED2024-12-04
00815991024054BodyMedBDMNTRGVSMBDMNTRGVSM2024-12-04
00815991024061BodyMedBDMNTRGVXLGBDMNTRGVXLG2024-12-04
00815991024078BodyMedBDMNTRGVXSBDMNTRGVXS2024-12-04
00815991024030BodyMedBDMNTRGVLRGBDMNTRGVLRG2024-12-04
20815991024041BodyMedBDMNTRGVMEDBDMNTRGVMED2024-12-04
20815991024058BodyMedBDMNTRGVSMBDMNTRGVSM2024-12-04
20815991024065BodyMedBDMNTRGVXLGBDMNTRGVXLG2024-12-04
20815991024072BodyMedBDMNTRGVXSBDMNTRGVXS2024-12-04
00815991025181BodyMedBDMPULSEOXBDMPULSEOX2024-10-11
20815991025185BodyMedBDMPULSEOXBDMPULSEOX2024-10-11
00815802010122BodyMedZZHP1427ZZHP14272016-09-05
00815802010139BodyMedZZHP1414ZZHP14142016-09-05
00815802010146BodyMedZZHP147ZZHP1472016-09-05
00815802010153BodyMedZZHP832UZZHP832U2016-09-05
00815802018715BodyMedZZHP1427BLKZZHP1427BLK2016-08-01
00815991022623BodyMedZZHPS1623ZZHPS16232019-10-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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MHC18602130N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
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