FDA.reportPublic FDA data

WellCare

Primary DI
00682670682597
Brand
WellCare
Company
Wellcare International, Inc.
Model
WNB703
Device description
WellCare 7 mil exam Blue nitrile gloves, size L, 100pcs/box, 10boxes/case
Published
2022-11-21
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
LZAPolymer Patient Examination Glove

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00682670682597PrimaryGS10
00682670681859Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00682670682597006826706825976826706825970682670682597
00682670681859006826706818596826706818590682670681859

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.

Regulatory Flags#

DUNS number
106246039
Device count
100
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850048808277WellCareWBK3012024-02-19
10850048808284WellCareWBK3022024-02-19
10850048808291WellCareWBK3032024-02-19
10850048808314WellCareWBK3042024-02-19
00661094556271WellCareENB3012022-11-01
00661094556288WellCareENB3022022-11-01
00661094556295WellCareENB3032022-11-01
00661094556301WellCareENB3042022-11-01
00682670681101WellCareWNGBK5052022-11-21
00682670682580WellCareWNB7022022-11-21
00682670682603WellCareWNB7042022-11-21
00682670682610WellCareWNB7052022-11-21
00682670682627WellCareWBK7022022-11-21
00682670682634WellCareWBK7032022-11-21
00682670682641WellCareWBK7042022-11-21
00682670682658WellCareWBK7052022-11-21
00712038257287WellCareWNGBK5012022-11-21
00712038347834WellCareWNGBK5022022-11-21
00712038347841WellCareWNGBK5032022-11-21
00712038347858WellCareWNGBK5042022-11-21

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