FDA.reportPublic FDA data

Covidien

Primary DI
10192253051216
Brand
Covidien
Company
Cardinal Health 200, LLC
Model
8881389459
Catalog number
8881389459
Device description
Isolator 10 mL Tubes, 50C7 Product, 16 x 100 mm, Abbott Diagnostics
Published
2025-01-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GIMTubes, Vacuum Sample, With Anticoagulant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIMTubes, Vacuum Sample, With AnticoagulantClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253051214PrimaryGS10
10192253051216Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225305121450192253051214
1019225305121610192253051216

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, anticoagulant/separatorA glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, an anticoagulant [e.g., ethylenediaminetetraacetic acid (EDTA), sodium heparin, sodium citrate, potassium oxalate], and a separator (e.g., gel) to separate blood plasma from cells. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., testing plasma in molecular diagnostics and viral load detection). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
400
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
false
Expiration date on label
true
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
10192253004649Monoject8602RC8602RC2026-07-09
10192253004656Monoject8605RC8605RC2026-07-09
10192253004663Monoject8607RC8607RC2026-07-09
10192253004700Monoject8617RC8617RC2026-07-09
10192253051575Precision2650SA2650SA2026-07-09
10197106896327CARDINAL HEALTHSNENU0868BSNENU0868B2026-07-09
10198956074668CARDINAL HEALTHSBA37OTMOFSBA37OTMOF2026-07-09
10198956119260CARDINAL HEALTHSBA69MPSUBSBA69MPSUB2026-07-09
10198956119437CARDINAL HEALTHPVVMVPBLGPVVMVPBLG2026-07-09
10198956255586CARDINAL HEALTHSOP53SAPTHSOP53SAPTH2026-07-09
10198956268272CARDINAL HEALTHSMA54CSWMMSMA54CSWMM2026-07-09
10198956286719CARDINAL HEALTHSOT11BR10MSOT11BR10M2026-07-09
10198956307308CARDINAL HEALTHSAN43ADSWOSAN43ADSWO2026-07-09
10198956313576CARDINAL HEALTHSMA69BTDNBSMA69BTDNB2026-07-09
10198956333888CARDINAL HEALTHPBCGLSARGPBCGLSARG2026-07-09
10198956334373CARDINAL HEALTHSNECGBPNODSNECGBPNOD2026-07-09
10198956339132CARDINAL HEALTHSEYHDCAGWHSEYHDCAGWH2026-07-09
10198956345942CARDINAL HEALTHSANOCIRHTBSANOCIRHTB2026-07-09
10198956349834CARDINAL HEALTHSAN73PLCHMSAN73PLCHM2026-07-09
10198956360358CARDINAL HEALTHSCV73VPBHDSCV73VPBHD2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20192253050988MonojectCardinal Health 200, LLCGIM2026-05-05
00850058457048BD MiniDraw Capillary Tube Adapter H&HBabson Diagnostics, Inc.GIM2025-12-09
00850058457055BD MiniDraw Finger Sizing ToolBabson Diagnostics, Inc.GIM2025-12-09
00382903666171BD MiniDraw Finger Sizing ToolBabson Diagnostics, Inc.GIM2025-12-09
10197106953433CARDINAL HEALTHCardinal Health 200, LLCGIM2025-03-28
50197106953431CARDINAL HEALTHCardinal Health 200, LLCGIM2025-03-28
50192253051214CovidienCardinal Health 200, LLCGIM2025-01-14
20192253051183MonojectCardinal Health 200, LLCGIM2024-10-08
50192253051184MonojectCardinal Health 200, LLCGIM2024-10-08
50382903666039BD MiniDraw™ H&H Capillary Blood Collection TubeBECTON, DICKINSON AND COMPANYGIM2024-06-06
50382903666138BD MiniDraw™ Finger Sleeve, SmallBECTON, DICKINSON AND COMPANYGIM2024-06-06
50382903666145BD MiniDraw™ Finger Sleeve, MediumBECTON, DICKINSON AND COMPANYGIM2024-06-06
50382903666152BD MiniDraw™ Finger Sleeve, LargeBECTON, DICKINSON AND COMPANYGIM2024-06-06
50382903666169BD MiniDraw™ Finger Sleeve, Extra-LargeBECTON, DICKINSON AND COMPANYGIM2024-06-06
50382903666176BD MiniDraw™ Finger Sizing ToolBECTON, DICKINSON AND COMPANYGIM2024-06-06
50382903666190BD MiniDraw™ Capillary Tube Adapter H&HBECTON, DICKINSON AND COMPANYGIM2024-06-06
30382903666134BD MiniDraw™ Finger Sleeve, SmallBECTON, DICKINSON AND COMPANYGIM2024-06-06
30382903666141BD MiniDraw™ Finger Sleeve, MediumBECTON, DICKINSON AND COMPANYGIM2024-06-06
30382903666158BD MiniDraw™ Finger Sleeve, LargeBECTON, DICKINSON AND COMPANYGIM2024-06-06
30382903666165BD MiniDraw™ Finger Sleeve, Extra-LargeBECTON, DICKINSON AND COMPANYGIM2024-06-06
30382903666172BD MiniDraw™ Finger Sizing ToolBECTON, DICKINSON AND COMPANYGIM2024-06-06
20192253050926MonojectCardinal Health 200, LLCGIM2024-02-28
20192253050940MonojectCardinal Health 200, LLCGIM2024-02-28
20192253050971MonojectCardinal Health 200, LLCGIM2024-02-28
20192253050995MonojectCardinal Health 200, LLCGIM2024-02-28
20192253051008MonojectCardinal Health 200, LLCGIM2024-02-28
20192253051015MonojectCardinal Health 200, LLCGIM2024-02-28
20192253051022MonojectCardinal Health 200, LLCGIM2024-02-28
20192253051039MonojectCardinal Health 200, LLCGIM2024-02-28
20192253051053MonojectCardinal Health 200, LLCGIM2024-02-28