FDA.reportPublic FDA data

Hopkins Medical Products®

Primary DI
00817643022036
Brand
Hopkins Medical Products®
Company
HOPKINS UNIFORM COMPANY
Model
575062-MED
Catalog number
575062-MED
Device description
Halyard Purple Nitrile Exam Gloves Medium Box 100
Published
2018-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer patient examination glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051347000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051347000KIMBERLY-CLARK* STERLING* NITRILE POWDER-FREE EXAMINATION GLOVEKimberly-Clark Corp.2005-06-07LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817643022036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817643022036008176430220368176430220360817643022036

GMDN Terms#

Term, Definition table
TermDefinition
Thermal vapour lung treatment system catheterA sterile flexible tube with an inflatable balloon at the distal end designed to deliver heated sterile water vapour into a lung affected by emphysema to achieve bronchoscopic lung volume reduction through the application of high thermal vapour energy to the lung segment targeted for treatment. The catheter is introduced via the working channel of a bronchoscope, the occlusion balloon is inflated in the airway, and thermal water vapour is released to produce a limited energy transfer which is restricted to the airways and diseased parenchyma in the targeted lung segment. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)835-1995customerservice@hopkinsmedical.net

Regulatory Flags#

DUNS number
003080678
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817643020421Hopkins Medical Products®6103886103882018-09-28
00817643021701Hopkins Medical Products®7129177129172018-09-28
00817643021718Hopkins Medical Products®7129187129182018-09-28
00817643021732Hopkins Medical Products®34212342122018-09-28
00817643021749Hopkins Medical Products®34213342132018-09-28
00817643022173Hopkins Medical Products®6118066118062018-09-28
00817643022180Hopkins Medical Products®6121456121452018-09-28
00817643022197Hopkins Medical Products®6133036133032018-09-28
00817643020780Hopkins Medical Products®6942626942622018-09-28
00817643020797Hopkins Medical Products®6942636942632018-09-28
00817643020803Hopkins Medical Products®6942656942652018-09-28
00817643020810Hopkins Medical Products®6942726942722018-09-28
00817643020827Hopkins Medical Products®6942736942732018-09-28
00817643020834Hopkins Medical Products®6942756942752018-09-28
00817643020841Hopkins Medical Products®6948626948622018-09-28
00817643020858Hopkins Medical Products®6948636948632018-09-28
00817643020865Hopkins Medical Products®6948656948652018-09-28
00817643020964Hopkins Medical Products®6952626952622018-09-28
00817643020971Hopkins Medical Products®6952636952632018-09-28
00817643021039Hopkins Medical Products®6982876982872018-09-28

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