FDA.reportPublic FDA data

Unimed

Primary DI
06936735478064
Brand
Unimed
Company
Unimed Medical Supplies, Inc.
Model
U1681D-C5555-10
Device description
Disposable NIBP Cuff Double tubes, TPU Cuff, with connectors Neonate
Published
2023-08-03
Public version status
Update
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
K120364000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120364000UNIMED DISPOSABLE BLOOD PRESSURE CUFFUnimed Medical Supplies, Inc.2012-05-04DXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06936735478064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936735478064069367354780646936735478064

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
527971025
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936735480913UnimedU708-912023-02-01
06945664833790UnimedHPMA5-90DS2016-08-22
06945664833837UnimedMQM5-90DS2016-08-22
06945664833875UnimedLQ5-90DP02016-08-22
06945664833905UnimedHTM5-90DS2016-08-22
06945664833974UnimedMQM3-90DS2016-08-22
06945664834063UnimedLQ5-90DS02016-08-22
06945664834186UnimedATM5-90DS2016-08-22
06945664834193UnimedD3M-90DS2016-08-22
06945664834209UnimedHPM3-90DS2016-08-22
06945664834254UnimedLDT3-90DP02016-08-22
06945664834414UnimedLHT5-90DP02016-08-22
06945664834452UnimedHP5-90DPM2016-08-22
06945664834469UnimedLPA5-90DS02016-08-22
06945664834537UnimedLPA5-90DP02016-08-22
06945664834735UnimedL5-90DP02016-08-22
06945664835046UnimedMQM5-90DP2016-08-22
06945664835077UnimedLKB6-90DP02016-08-22
06945664835084UnimedL3-90DP02016-08-22
06945664835640UnimedLHT5-90DS02016-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06971996170173MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170180MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170197MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07
06971996170203MinhuaSuzhou Minhua Medical Apparatus Supplies Co., Ltd.DXQ2026-08-07