AccessGUDID - DEVICE: Halyard (10680651472011)

GUDID

Device Identifier (DI) Information

Brand Name: Halyard
Version or Model: 47201
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20-0950
Company Name: Avanos Medical, Inc.

Primary DI Number: 10680651472011
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079375431 *Terms of Use

Device Description: HALYARD CORTRAK 2 Enteral Access System

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?
59078	Enteral tube tracking system	A mains electricity (AC-powered) portable electronic device assembly, typically with rechargeable battery, designed to detect, record, and display an electromagnetic (EM) signal emitted from a transmitter in an enteral feeding tube stylet to facilitate the placement of the enteral tube, by providing a graphic display representing the path of the tube tip. It consists of an electromagnetic receiver placed on the epigastrium, a visual display/control unit which displays real-time anterior and cross-sectional representational views of the transmitter location and track, and a separately supplied single-use enteral feeding tube stylet which incorporates an electromagnetic transmitter in the tip.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNT	TUBES, GASTROINTESTINAL (AND ACCESSORIES)

FDA Premarket Submission

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

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5da463d0-8ab1-4743-b08d-6391df1c4f56
Public Version Date: November 16, 2018
Public Version Number: 3
DI Record Publish Date: October 31, 2017

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

Customer Contact

[?]

Phone: +1(847)403-3400
Email: questions@corpak.com

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