FDA.reportPublic FDA data

Medichoice

Primary DI
10885632143946
Brand
Medichoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
CL8801
Device description
Cable Adapter Ibp 11 Pin 4.0m Edwards Compatible Reusable Not Made With Natural Rubber Latex MediChoice
Published
2016-08-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885632143946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088563214394610885632143946

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical cable adaptorA small connector used to join the cable(s) from a handpiece/electrode(s) (active and/or return) to the generator of an electrosurgical system. This device will typically be used when the system components are from different manufacturers and the connections are not compatible. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit40 Degrees Fahrenheit
Special Storage Condition, Specify00
Special Storage Condition, Specify00Avoid Freezing and Excessive Heat

Regulatory Flags#

DUNS number
007941230
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

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Primary DI, Brand, Model table
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10885632509063Halyard620762026-05-22
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10885632521751SurgiTrackSM450130D17D2026-05-22
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10885632521591SurgiTrackSM45004113802026-05-18
10885632521317SurgiTrackSM450178CA972026-05-13

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