FDA.reportPublic FDA data

NuvoMed

Primary DI
00810110303508
Brand
NuvoMed
Company
NUVOMED, INC.
Model
NABP-6/0350
Device description
Arm Blood Pressure Monitor
Published
2024-10-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K222125000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222125000Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30GShenzhen AOJ Medical Technology Co., Ltd.2022-12-01DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810110303508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810110303508008101103035088101103035080810110303508

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

Regulatory Flags#

DUNS number
080809709
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859811007063NuvoMedBGTS50-24/07682018-09-04
00859811007681NuvoMed BGTS50-24/07682018-08-28
00859811009241NuvoMedTDT-6/09242020-10-30
00859811009234NuvoMedTBP-6/09232020-10-30
00859811009258NuvoMedTOS-6/09252020-10-30
00810110302099NuvoMedCTSS-12/02092024-03-22
00810110302105NuvoMedCTSL-12/02102024-03-22
00810110302112NuvoMedCTSX-12/02112024-03-22
00810110302129NuvoMedCTFP-6/02122024-03-22
00810110303492NuvoMedNWBP-6/03492024-10-18
00810110303676NuvoMedLOS-12/03672024-12-13
00859811008947NuvoMedDCT-6/08942024-12-13
00859811007391NuvoMedFPO-6/07392018-09-10
00859811007261NuvoMedNGS50-24/07262019-01-29
00859811007414NuvomedMBG10-6/07412019-01-29
00810110302075NuvoMedBPMC-6/02072023-12-05
00859811007025NuvoMedNIET-6/07022018-06-15
00859811007018NuvoMedNBPM-6/07012018-06-15
00859811008510Bella RussoINV005642019-06-05
00859811007407NuvoMedTTM-6/07402018-09-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00885403529637Acumen IQBecton, Dickinson And CompanyDXN2026-07-29
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00194346614035equateWAL-MART STORES, INC.DXN2026-07-28
06953825911683SAKER UltraShenzhen Urion Technology Co., LtdDXN2026-07-27
06953825911645N/AShenzhen Urion Technology Co., LtdDXN2026-07-24
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00073796392437SMALL D-RING CUFFOmron Healthcare, Inc.DXN2026-07-20
00816042016516FORAFORA CARE INC.DXN2026-07-20
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00850078377234iHealthiHealth Labs Inc.DXN2026-07-14
06953825911416N/AShenzhen Urion Technology Co., LtdDXN2026-07-13