FDA.reportPublic FDA data

MEDLINE

Primary DI
20197344135858
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
MDS0167104
Catalog number
MDS0167104
Device description
BLADE,LARYNG,SINGLE USE,KESSEL4
Published
2025-08-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCWLARYNGOSCOPE, RIGID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20197344135858PackageGS110In Commercial Distribution
10197344135851PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019734413585820197344135858
1019734413585110197344135851

GMDN Terms#

Term, Definition table
TermDefinition
Microscope slide hybridization/denaturation incubator IVDA mains electricity (AC-powered) laboratory instrument intended to be used for the incubation of microscope slides for the denaturation and/or hybridization of a clinical specimen as part of an in situ hybridization (ISH) and/or fluorescence in situ hybridisation (FISH) protocol. It is typically a bench-top unit with the capacity to hold multiple previously-prepared slides (i.e., fixed slides with/without added reagents) and is programmable to provide an optimum environment for ISH/FISH procedures (e.g., by controlling temperature, humidity and incubation time).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
10653160393900MEDLINEBSIPIV1023BSIPIV10232026-10-01
10888277664395MEDLINEMPHUA120MPMPHUA120MP2026-10-01
20080196181893GeminiGEM1148SGEM1148S2016-10-14
20080196181954GeminiGEM2112SGEM2112S2016-10-14
20080196187307GeminiGEM5172SGEM5172S2016-10-14
20080196921208GeminiGEM2112GEM21122016-10-14
20888277655499MEDLINEMLABTP12GENMLABTP12GEN2026-10-01
10193489011265GeminiGEMTITAN54TGEMTITAN54T2021-05-26
10197344149018GeminiGEMTITAN18TCGEMTITAN18TC2025-08-14
10884389112076MEDLINE INDUSTRIES, INC.EQX7022EQX70222021-05-18
10884389121740MEDLINE INDUSTRIES, INC.EQX7044EQX70442021-05-18
10884389931950MEDLINE INDUSTRIES, INC.MSC7348EPMSC7348EP2021-05-18
20080196181152GeminiGEM1124SGEM1124S2016-10-14
20080196181367GeminiGEM1130SGEM1130S2016-10-14
20080196181428GeminiGEM1136SGEM1136S2016-10-14
20080196181565GeminiGEM1140SGEM1140S2016-10-14
20080196921130GeminiGEM1124GEM11242016-10-14
20080196921178GeminiGEM1145GEM11452016-10-14
20197344695314GeminiGEM5172SCGEM5172SC2024-07-15
20197344695321GeminiGEM5172TCGEM5172TC2024-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971834830016Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830023Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830030Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830047Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830542Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830559Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830566Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830573Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830580Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830597Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830603Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830610Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830627Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830634Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830641Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830658Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830665Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830672Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830689Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830696Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830702Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830719Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830726Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834831235Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834831242Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834831259Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834831266Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834831273Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834831280Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834831310Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30