AccessGUDID - DEVICE: 7 Fr PV-Catheter (08719327737347)

GUDID

Device Identifier (DI) Information

Brand Name: 7 Fr PV-Catheter
Version or Model: CA-71123-PL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CDL018
Company Name: CD Leycom

Primary DI Number: 08719327737347
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 414947457 *Terms of Use

Device Description: 7 Fr PV-Loop catheter with 12 mm electrode spacing

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
11434	Intracardiac catheter-tip electrode	An electrical conductor located at one end of an appropriate flexible catheter (not included) which is inserted into the chambers of the heart in order for the electrode to detect the presence of certain indicators to measure cardiac output. The relayed signals from the electrode can help the operator determine the presence of left-to-right heart shunt. The electrical conductor may also be used to characterize the electrical activity of the heart. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OBJ	Catheter, Ultrasound, Intravascular
DQO	Catheter, Intravascular, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K030524	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 997378b2-1bba-4cf6-b0e0-bdac17cd5fa7
Public Version Date: September 28, 2023
Public Version Number: 1
DI Record Publish Date: September 20, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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