FDA.reportPublic FDA data

Medichoice

Primary DI
20885632147033
Brand
Medichoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
PA1012
Device description
Kit Port Disposable/sngle Use Fda Class Ii Not Nat Rubber Ltx MediChoice
Published
2016-08-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
20885632147033PackageGS120In Commercial Distribution
10885632147036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088563214703320885632147033
1088563214703610885632147036

GMDN Terms#

Term, Definition table
TermDefinition
Vascular access device flush/disinfection toolA manual device intended to be used to flush wash the lumen of an in situ vascular access device (e.g., catheter, needleless intravenous line) and to disinfect the device’s Luer access valve. It consists of a prefilled syringe containing a saline solution, and a disinfection cap or scrubber containing a foam material saturated with disinfectant [e.g., isopropyl alcohol (IPA)]. It may be supplied as a one-piece or modular device. 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
10885632521607SurgiTrackSM4500452F842026-05-19
10885632521638SurgiTrackSM45007841332026-05-19
10885632521522SurgiTrackSM4500410A672026-05-18
10885632521577SurgiTrackSM450041BC2C2026-05-18
10885632521584SurgiTrackSM45004117402026-05-18
10885632521591SurgiTrackSM45004113802026-05-18
10885632521317SurgiTrackSM450178CA972026-05-13
10885632434228Halyard563442026-05-12

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Primary DI, Brand, Company table
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