FDA.reportPublic FDA data

BARCODE SCANNER GUN GEM 3000

Primary DI
08426950895978
Brand
BARCODE SCANNER GUN GEM 3000
Company
INSTRUMENTATION LABORATORY COMPANY
Model
00024000130
Catalog number
00024000130
Device description
BARCODE SCANNER GUN GEM 3000
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
CHLELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950895978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950895978084269508959788426950895978

GMDN Terms#

Term, Definition table
TermDefinition
Barcode readerA device that reads and interprets barcodes of various format. A barcode is typically an electronically readable information strip consisting of parallel, vertical stripes and spaces of variable thicknesses which can also be presented in two or more layered information levels. This device may have the capability of storing the read data and downloading this into other data systems when this is required.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)678-0710techsupport@ilww.com
+1-800-678-0710techsupport@werfen.com
+1-800-678-0710techsupport.na@werfen.com

Regulatory Flags#

DUNS number
557223252
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
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
08430793242998HEMOSIL RIVAROXABAN CONTROLS0020015500000200155002024-07-22
08430793243001HEMOSIL RIVAROXABAN CALIBRATORS0020015400000200154002024-07-22
00195226001129HemosIL Chromogenic Factor IX002001290000200129002024-07-09
00195226000528ACL TOP 77000000280057000002800572024-05-15
00195226000535ACL TOP 770 LAS00000280037000002800372024-05-15
00195226000542ACL TOP 770s00000280017000002800172024-05-15
00195226000559ACL TOP 57000000280047000002800472024-05-15
00195226000566ACL TOP 37000000280067000002800672024-05-15
00195226000641GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 300 Tests)000774300102023-10-03
00195226000627GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 600 Tests)000774450102023-10-02
00195226000634GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 450 Tests)000774450102023-10-02
00195226000658GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 150 Tests)000774150102023-10-02
00195226000665GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 75 Tests)000774075102023-10-02
00195226000672GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 600 Tests)000773600112023-10-02
00195226000689GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 450 Tests)000774450112023-10-02
00195226000696GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 300 Tests)000774450102023-10-02
00195226000702GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 150 Tests)000774450102023-10-02
00195226000719GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 75 Tests)000774450102023-10-02
00195226000726GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX 600 Tests)000773600082023-10-02
00195226000733GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX 450 Tests)000774450082023-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10054749005670i-STAT G3+ CartridgeAbbott Point of Care Inc.CHL2023-12-18
00195226000641GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 300 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-03
00195226000627GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 600 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-02
00195226000634GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 450 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-02
00195226000658GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 150 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-02
00195226000665GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 75 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-02
00195226000672GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 600 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-02
00195226000689GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 450 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-02
00195226000696GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 300 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-02
00195226000702GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 150 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-02
00195226000719GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 75 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-02
00195226000726GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX 600 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-02
00195226000733GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX 450 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-02
00195226000740GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX 300 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-02
00195226000757GEM Premier 7000 with iQM3 PAK (7k BG/ISE/COOX 150 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-02
00195226000764GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX 75 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-02
00195226000771GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX/Tbili 600 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-02
00195226000788GEM Premier 7000 with iQM3 PAK (BG/ISE/CO-Ox/Tbili 450 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-02
00195226000795GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX/Tbili 300 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-02
00195226000801GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX/Tbili 150 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-02
00195226000818GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX/Tbili 75 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-02
00195226000825GEM Premier 7000 with iQM3 PAK (BG/COOX 600 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-02
00195226000832GEM Premier 7000 with iQM3 PAK (BG/COOX 450 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-02
00195226000849GEM Premier 7000 with iQM3 PAK (BG/COOX 300 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-02
00195226000856GEM Premier 7000 with iQM3 PAK (BG/COOX 150 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-02
00195226000863GEM Premier 7000 with iQM3 PAK (BG/COOX 75 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-02
00195226000870GEM Premier 7000 with iQM3 PAK (BG/COOX/Tbili 600 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-02
00195226000887GEM Premier 7000 with iQM3 PAK (BG/COOX/Tbili 450 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-02
00195226000894GEM Premier 7000 with iQM3 PAK (BG/COOX/Tbili 300 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-02
00195226000900GEM Premier 7000 with iQM3 PAK (BG/COOX/Tbili 150 Tests)INSTRUMENTATION LABORATORY COMPANYCHL2023-10-02