AccessGUDID - DEVICE: Halyard (10680651467185)

GUDID

Device Identifier (DI) Information

Brand Name: Halyard
Version or Model: 46718
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: N58913
Company Name: Avanos Medical, Inc.

Primary DI Number: 10680651467185
Issuing Agency: GS1
Commercial Distribution End Date: February 28, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 079375431 *Terms of Use

Device Description: N58913 HYH,10CCSY,PLASYR,-,-,25

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):	No
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?
58220	Manual epidural space locator	A sterile device intended to be used in conjunction with an epidural needle to aid a user in locating the epidural needle tip within the epidural space. It is typically a small chamber made of synthetic polymers with Luer inlet and exit ports on opposing sides and an expandable membrane (diaphragm) as one of the sides between the ports. The device is inserted between the syringe and epidural needle and its diaphragm is inflated with air; the needle is inserted into the patient until the diaphragm collapses signalling entry into the epidural space. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMF	Syringe, piston

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K941562	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: ef946c6e-aa82-449a-a012-16d930115ba6
Public Version Date: February 28, 2024
Public Version Number: 6
DI Record Publish Date: December 21, 2017