FDA.reportPublic FDA data

Medichoice

Primary DI
20885632147255
Brand
Medichoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
PA1007C
Device description
Tray Port Access Gloves Not Included Tegaderm Gauze Skin Closure Tape Chloraprep No Sting Swab Mask Hand Sanitizer White Paper
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
OFFCentral venous catheter tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFFCentral Venous Catheter TrayCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885632147255PackageGS130In Commercial Distribution
10885632147258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088563214725520885632147255
1088563214725810885632147258

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00
Special Storage Condition, Specify00Avoid freezing and excessive heat

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
10885632434266Halyard563482026-05-22
10885632434303Halyard563522026-05-22
10885632468490Halyard614862026-05-22
10885632468506Halyard614872026-05-22
10885632468513Halyard614882026-05-22
10885632468520Halyard614892026-05-22
10885632509032Halyard620732026-05-22
10885632509049Halyard620742026-05-22
10885632509056Halyard620752026-05-22
10885632509063Halyard620762026-05-22
10885632510199Halyard620772026-05-22
10885632521751SurgiTrackSM450130D17D2026-05-22
10885632517105SurgiTrackSM4500410F102026-03-23
10885632516429SurgiTrackSM4500309F242026-03-17
30885632495469HalyardIDSG10012026-03-13
20885632495851HalyardIDSG10022026-03-13
20885632495868HalyardIDSG10032026-03-13
20885632495875HalyardIDSG10042026-03-13
20885632495882HalyardIDSG10052026-03-13
20885632496742HalyardIDSG10062026-03-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20809160515027Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFF2026-03-04
50198956373165CARDINAL HEALTHCardinal Health 200, LLCOFF2026-03-03
50198956326369CARDINAL HEALTHCardinal Health 200, LLCOFF2026-03-02
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50198956326277CARDINAL HEALTHCardinal Health 200, LLCOFF2026-02-13
20809160512255MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OFF2026-02-11
50198956344592CARDINAL HEALTHCardinal Health 200, LLCOFF2026-02-09
50198956350661CARDINAL HEALTHCardinal Health 200, LLCOFF2026-02-09
50198956351880CARDINAL HEALTHCardinal Health 200, LLCOFF2026-02-09
50198956325058CARDINAL HEALTHCardinal Health 200, LLCOFF2026-01-15
00191072241597ACSAMERICAN CONTRACT SYSTEMS, INC.OFF2026-01-14
00191072241399ACSAMERICAN CONTRACT SYSTEMS, INC.OFF2026-01-06
00191072241405ACSAMERICAN CONTRACT SYSTEMS, INC.OFF2026-01-06
50198956302943CARDINAL HEALTHCardinal Health 200, LLCOFF2025-12-26
20809160506650Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFF2025-12-17
50198956285864CARDINAL HEALTHCardinal Health 200, LLCOFF2025-12-11
50198956263688CARDINAL HEALTHCardinal Health 200, LLCOFF2025-12-10
20809160495183Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFF2025-09-24
50198956070729CARDINAL HEALTHCardinal Health 200, LLCOFF2025-08-28
20809160492755MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OFF2025-08-25
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40198459472696MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFF2025-08-18
40198459481551MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFF2025-08-18
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