FDA.reportPublic FDA data

Medline

Primary DI
30817357022149
Brand
Medline
Company
HYGIA HEALTH SERVICES, INC.
Model
MDS9913HP
Device description
MEDLINE CUFF, BP, DIS, 1T, 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
Rx
false
OTC
false
Sterile
false
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
30817357022149PackageGS120Not in Commercial Distribution
10817357022145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081735702214930817357022149
1081735702214510817357022145

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
177939027
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
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
10817357022237MedlineHYGIA 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
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