FDA.reportPublic FDA data

Medline

Primary DI
10817357022237
Brand
Medline
Company
HYGIA HEALTH SERVICES, INC.
Model
MDS9912HP
Device description
MEDLINE CUFF, BP, DIS, 1T, SM ADL, HP
Published
2017-02-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NPPReprocessed Blood Pressure Cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPPReprocessed Blood Pressure CuffCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032821000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032821000HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFFHygia Health Services, Inc.2003-12-05NPP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30817357022231PackageGS120Not in Commercial Distribution
10817357022237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081735702223130817357022231
1081735702223710817357022237

GMDN Terms#

Term, Definition table
TermDefinition
Blood pressure cuff, reprocessedA band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) intended to 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 previously used single-use device that has been processed for an additional single-use patient application.

Regulatory Flags#

DUNS number
177939027
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817357021704Mabis10-428-0802016-09-24
10817357021797Mabis10-426-0202016-09-24
10817357021940Mabis10-426-0802016-09-24
10817357021957Mabis10-428-0102016-09-24
10817357021995Mabis10-428-0202016-09-24
10817357021179Stryker5921-034-2352018-05-04
10817357021261Zimmer60-7070-1032018-01-15
10817357021278Zimmer60-7070-1062018-01-15
10817357021438Stryker5921-218-2352018-05-04
10817357021469Zimmer60-7070-1042018-03-02
10817357021575Zimmer60-7070-1052018-01-15
10817357021735Stryker5921-218-1352018-03-03
10817357021841Stryker5921-034-1352018-03-02
10817357021919Stryker5921-024-2352018-05-04
10817357022022Stryker5921-044-2352018-05-04
10817357022169Stryker5921-030-1352018-03-02
10817357022350Stryker5921-018-1352018-02-16
10817357022435Zimmer60-7075-1032018-02-16
10817357022442Zimmer60-7075-1062018-02-16
10817357022459Zimmer60-7075-1052018-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860005485802Bio Centric IncBIO CENTRIC INC.NPP2020-12-01
08600054858002Bio Centric IncBIO CENTRIC INC.NPP2020-12-01
10817357022503Nova PlusHYGIA HEALTH SERVICES, INC.NPP2018-06-22
10817357022510Welch AllynHYGIA HEALTH SERVICES, INC.NPP2018-06-22
30817357022507Nova PlusHYGIA HEALTH SERVICES, INC.NPP2018-06-22
30817357022514Welch AllynHYGIA HEALTH SERVICES, INC.NPP2018-06-22
10817357022312Welch AllynHYGIA HEALTH SERVICES, INC.NPP2017-06-24
10817357022329CritikonHYGIA HEALTH SERVICES, INC.NPP2017-06-24
30817357022316Welch AllynHYGIA HEALTH SERVICES, INC.NPP2017-06-24
30817357022323CritikonHYGIA HEALTH SERVICES, INC.NPP2017-06-24
10817357022305CritikonHYGIA HEALTH SERVICES, INC.NPP2017-04-08
30817357022309CritikonHYGIA HEALTH SERVICES, INC.NPP2017-04-08
10817357022275MedlineHYGIA HEALTH SERVICES, INC.NPP2017-02-25
10817357022282Welch AllynHYGIA HEALTH SERVICES, INC.NPP2017-02-25
30817357022279MedlineHYGIA HEALTH SERVICES, INC.NPP2017-02-25
30817357022286Welch AllynHYGIA HEALTH SERVICES, INC.NPP2017-02-25
10817357022145MedlineHYGIA HEALTH SERVICES, INC.NPP2017-02-04
10817357022206Cardinal HealthHYGIA HEALTH SERVICES, INC.NPP2017-02-04
10817357022213Cardinal HealthHYGIA HEALTH SERVICES, INC.NPP2017-02-04
10817357022220MedlineHYGIA HEALTH SERVICES, INC.NPP2017-02-04
10817357022244MedlineHYGIA HEALTH SERVICES, INC.NPP2017-02-04
10817357022251MedlineHYGIA HEALTH SERVICES, INC.NPP2017-02-04
10817357022268MedlineHYGIA HEALTH SERVICES, INC.NPP2017-02-04
30817357022149MedlineHYGIA HEALTH SERVICES, INC.NPP2017-02-04
30817357022200Cardinal HealthHYGIA HEALTH SERVICES, INC.NPP2017-02-04
30817357022217Cardinal HealthHYGIA HEALTH SERVICES, INC.NPP2017-02-04
30817357022224MedlineHYGIA HEALTH SERVICES, INC.NPP2017-02-04
30817357022231MedlineHYGIA HEALTH SERVICES, INC.NPP2017-02-04
30817357022248MedlineHYGIA HEALTH SERVICES, INC.NPP2017-02-04
30817357022255MedlineHYGIA HEALTH SERVICES, INC.NPP2017-02-04