FDA.reportPublic FDA data

Claricuff™

Primary DI
B593CSST2635HP0
Brand
Claricuff™
Company
Ningbo Albert Novosino Co.,Ltd.
Model
Tapmedic
Device description
Claricuff™ Non-Invasive Blood Pressure Cuffs and Accessories
Published
2018-03-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DXQBlood Pressure Cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXQBlood Pressure CuffCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173044000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173044000Reusable Blood Pressure Cuff, Disposable Blood Pressure CuffNingbo Albert Novosino Co., Ltd.2017-11-20DXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B593CSST2635HP0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Blood pressure cuff, single-useA band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is typically wrapped around the upper arm of the patient. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
543014978
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16971919462528Medi Grade2L2025-12-29
16971919462535Medi Grade60ml2025-12-29
16971919460500Medi Grade20ML2025-11-20
16971919460449Medi Grade500ml2025-11-17
16971919460494Medi Grade90ml2025-11-17
16971919460432Medi Grade75ml2025-11-11
06971919466949noneER813B2023-10-26
06971919462156noneIBS0012025-03-14
06971919460602BieglerJR60010002024-05-24
06971919460619BieglerJR60030002024-05-24
06971919460626BieglerJR50502012024-05-24
06971919460633BieglerJR60602012024-05-24
06971919460657BieglerJR50503012024-05-24
06971919460664BieglerJR60603012024-05-24
06971919461395PREMIUM2L2024-03-11
06971919461401PREMIUM2L2024-03-11
06971919460725ClarifloRU1000PGS2023-04-20
06971919460732ClarifloRU3000PGS2023-04-20
09369998205660Migraine stopper1.02023-05-31
06971919466253Migraine StopperA/02022-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00859140003200DealmedDEALMED MEDICAL SUPPLIES LLCDXQ2026-10-08
00859140003217DealmedDEALMED MEDICAL SUPPLIES LLCDXQ2026-10-08
00634782102449Multikuf™AMERICAN DIAGNOSTIC CORPDXQ2026-10-06
00634782102517ADCAMERICAN DIAGNOSTIC CORPDXQ2026-10-06
00634782102159Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782102166Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782102173Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782102197Adcuff™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782102203Adcuff™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782102210Adcuff™AMERICAN DIAGNOSTIC CORPDXQ2026-08-26
00634782101459Prosphyg™AMERICAN DIAGNOSTIC CORPDXQ2026-08-25
00634782102180Diagnostix™AMERICAN DIAGNOSTIC CORPDXQ2026-08-25
06975185470358LightningWenzhou Kangshun Medical Devices CO.,LTDDXQ2026-08-08
06971996170005MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170012MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170029MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170036MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170043MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170050MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170067MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170074MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170081MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170098MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170104MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170111MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170128MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170135MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170142MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170159MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170166MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07