FDA.reportPublic FDA data

Medichoice

Primary DI
50885632109223
Brand
Medichoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
CLC3001
Device description
Tray Dressing Change Chloraprep 3Milliliter Tegaderm Alcohol Swab 4X4In Gauze Drape Glove Mask Label Latex-Free Sterile MediChoice
Published
2016-08-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PEZCentral venous catheter dressing change kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEZCentral Venous Catheter Dressing Change KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885632109223PackageGS130In Commercial Distribution
10885632109225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088563210922350885632109223
1088563210922510885632109225

GMDN Terms#

Term, Definition table
TermDefinition
Arterial/central venous catheterization support/maintenance kitA collection of sterile devices intended to support the catheterization procedure of an artery and/or central vein (large veins of the upper body), and/or to provide ongoing vascular catheter maintenance. It is primarily intended to be used at the patient’s bedside and includes devices intended to support catheter placement and/or or ongoing maintenance (e.g., dressing change, catheter flushing) such as: disposable drapes, disinfectant wipes, dressings, gown, tourniquets, ultrasound system transducer cover, coupling gel, sharps container, syringe, and saline solution; neither the catheter, catheter introduction device, nor pharmaceuticals are included. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007941230
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885632524806SurgiTrackSM450045C32D2026-07-06
10885632524820SurgiTrackSM4500415EA72026-07-06
10885632524844SurgiTrackSM45004133CC2026-07-06
10885632230394SurgiTrackSM450020840E2019-03-07
10885632522819SurgiTrackSM450087976F2026-06-08
10885632506000HalyardNADSG2012026-06-05
10885632506017HalyardNADSG2022026-06-05
10885632506024HalyardNADSG2032026-06-05
10885632522642SurgiTrackSM45013041502026-06-05
10885632522659SurgiTrackSM4501306C1C2026-06-05
10885632522543SurgiTrackSM450030A7E12026-06-04
10885632522512SurgiTrackSM45004591012026-06-03
10885632522222SurgiTrackSM45005945A12026-06-01
10885632522109SurgiTrackSM4501306C092026-05-29
10885632522079SurgiTrackSM450045D71A2026-05-28
10885632434266Halyard563482026-05-22
10885632434303Halyard563522026-05-22
10885632468490Halyard614862026-05-22
10885632468506Halyard614872026-05-22
10885632468513Halyard614882026-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160526750MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PEZ2026-07-06
10809160526774HALYARDMEDICAL ACTION INDUSTRIES INC.PEZ2026-07-06
10809160526781HALYARDMEDICAL ACTION INDUSTRIES INC.PEZ2026-07-06
10809160522790Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEZ2026-06-05
10198956473324CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-05-08
10198956085138CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-04-30
10198956435254CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-04-27
10198956459212CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-04-21
10198956334274CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-04-07
10198956340183CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-04-07
10198956415966CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-04-07
10198956359444CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-04-06
10198956416161CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-04-06
10198956363496CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-03-31
10198956390324CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-03-23
10198956412163CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-03-23
10198956348332CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-03-19
10198956391864CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-03-19
10198956408791CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-03-10
10198956372887CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-03-02
10198956348325CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-02-23
10198956339118CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-02-13
10198956339989CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-02-02
10198956322349CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-01-29
10198956269514CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-01-05
10198956269354CARDINAL HEALTHCardinal Health 200, LLCPEZ2025-12-19
10198956236929CARDINAL HEALTHCardinal Health 200, LLCPEZ2025-12-17
10198956253919CARDINAL HEALTHCardinal Health 200, LLCPEZ2025-11-14
10198956256552CARDINAL HEALTHCardinal Health 200, LLCPEZ2025-11-06
10198956238978CARDINAL HEALTHCardinal Health 200, LLCPEZ2025-10-27