DEVICE: Kendall (10884521212640)

Device Identifier (DI) Information

Kendall
33136RT36
In Commercial Distribution
33136RT36
Cardinal Health, Inc.
10884521212640
GS1

1
080935429 *Terms of Use
DL Disposable Lead Set 5 Lead, Radiolucent
CLOSE

Device Characteristics

MR Unsafe
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
36038 Radiolucent electrocardiographic lead
A radiolucent insulated metal or non-metallic wire(s) with an electrode used to conduct electrical signals from a patient's heart, via the electrode which is attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine. It is typically used during cardiac catheterization procedures because it will cast a slight or negligible shadow on the radiographic images. This is a reusable device.
Obsolete false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
IKD CABLE, ELECTRODE
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: ;
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 3 Feet
CLOSE

Device Record Status

ed0ee4b0-a20d-4528-a8b5-62f91cbc8db6
February 15, 2019
5
September 24, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20884521212647 10 10884521212640 In Commercial Distribution PACK_OR_INNER_PACK
30884521212644 100 10884521212640 In Commercial Distribution CASE
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(508)261-8000
covidien.udi@covidien.com
CLOSE