AccessGUDID - DEVICE: NA (00643169352650)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 1035Y
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00643169352650
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: CONNECTOR 1035Y Y GLOBAL ROHS

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:	No
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?
45808	Vacuum quick-connect coupling, male	A male connecting device intended to be used to connect to a medical gas/vacuum pipeline system or other vacuum connection allowing a user to rapidly connect and disconnect vacuum dependent devices to the vacuum source. It has safety features such as a specific mechanical mating pattern, colour coding and a dedicated tube diameter connection to prevent wrong connection. It is used to connect into a vacuum terminal unit or female connector. It can be designed as a diameter-indexed safety system (DISS) connector or a non-interchangeable screw-threaded (NIST) connector.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LPB	Cardiac ablation percutaneous catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P020045	065

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit
Handling Environment Humidity: less than 85 Percent (%) Relative Humidity
Handling Environment Temperature: between -31 and 136 Degrees Fahrenheit
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 73ac8406-af25-45d4-923a-11ae11536b5f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: May 19, 2015

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: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)633-8766
Email: Corporate.UDI@medtronic.com

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