AccessGUDID - DEVICE: Lyka® PORT Needle Free Access Device (00634624417021)

GUDID

Device Identifier (DI) Information

Brand Name: Lyka® PORT Needle Free Access Device
Version or Model: 4170Y
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: QUEST MEDICAL INC

Primary DI Number: 00634624417021
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041810693 *Terms of Use

Device Description: No description.

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":	Yes
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?
63440	Haemodialysis tubing valve-connector	A small, sterile, stand-alone, Luer-activated plastic valve intended to be connected to a haemodialysis catheter to allow external tubing to be connected to the catheter in a secure, sealed, locked position until disconnection of the tubing, whereupon it is designed to seal the catheter (i.e., between haemodialysis therapies). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPA	Set, Administration, Intravascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K241058	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: d744711c-518f-46bc-adbb-3763e2645e5e
Public Version Date: June 20, 2025
Public Version Number: 1
DI Record Publish Date: June 12, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10634624417028	50	00634624417021		In Commercial Distribution	Carton
20634624417025	4	10634624417028		In Commercial Distribution	Shipper

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

Customer Contact

[?]

Phone: +1 800-627-0226
Email: custserv@questmedical.com

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