FDA.reportPublic FDA data

BioSkin

Primary DI
00850017044920
Brand
BioSkin
Company
LIBERTY GLOVE & SAFETY, LLC
Model
2016BKMLM
Device description
Black PF nitrile glove, 100pcs/bx
Published
2024-08-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00850017044920PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017044920008500170449208500170449200850017044920

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

Regulatory Flags#

DUNS number
111313244
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810175570068BioSkinF2010MLC2XL2024-11-18
00810175570150BioSkinF2010MLC2XL2024-11-18
00810175570105BioSkinF2010MLCXS2024-08-26
00810175570112BioSkinF2010MLCXS2024-08-26
00810175570129BioSkin2810MLXS2024-08-26
00810175570136BioSkin2810MLXS2024-08-26
00850017044081BioSkinF2010MLCL2024-08-26
00850017044098BioSkinF2010MLCL2024-08-26
00850017044104BioSkinF2010MLCM2024-08-26
00850017044111BioSkinF2010MLCM2024-08-26
00850017044128BioSkinF2010MLCS2024-08-26
00850017044135BioSkinF2010MLCS2024-08-26
00850017044142BioSkinF2010MLCXL2024-08-26
00850017044159BioSkinF2010MLCXL2024-08-26
00850017044234BioSkin2810MLL2024-08-26
00850017044241BioSkin2810MLL2024-08-26
00850017044258BioSkin2810MLM2024-08-26
00850017044265BioSkin2810MLM2024-08-26
00850017044272BioSkin2810MLS2024-08-26
00850017044289BioSkin2810MLS2024-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197344133812MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133836MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133850MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133874MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133898MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00726893120754TrustexGLOBAL PROTECTION CORP.LZA2026-06-04
08859826311003LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826312000LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826313007LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826314004LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZA2026-06-04
00194346693122EquateWAL-MART STORES, INC.LZA2026-06-02
00194346693139EquateWAL-MART STORES, INC.LZA2026-06-02
00768627017282Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017299Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017305Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017312Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
10840330702208ProCureTwin Med, LLCLZA2026-06-01
10840330702215ProCureTwin Med, LLCLZA2026-06-01
10840330702222ProCureTwin Med, LLCLZA2026-06-01
10840330702239ProCureTwin Med, LLCLZA2026-06-01