AccessGUDID - DEVICE: OnGaurd2 CSTD Catheter Adaptor (27290115921827)

GUDID

Device Identifier (DI) Information

Brand Name: OnGaurd2 CSTD Catheter Adaptor
Version or Model: 412182
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SIMPLIVIA HEALTHCARE LTD

Primary DI Number: 27290115921827
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 521161349 *Terms of Use

Device Description: The product is part of OnGuard2 Chemfort system for use with Chemfort / OnGuard2 CSTD Syringe Adaptor / Syringe Adaptor Lock The distal end of the Catheter Adaptor connect to a urinary catheter The proximal end of e Catheter Adaptor connects to Syringe Adaptor / Syringe Adaptor Lock

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?
41222	Medication transfer set	A collection of sterile devices and supplies designed to transfer parenteral medications, and sometimes intravenous (IV) fluids, between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it may also be used to reconstitute medication for its preparation and administration. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ONB	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K231286	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: d4434b4b-1f67-4725-9c49-e13e615225c6
Public Version Date: September 20, 2023
Public Version Number: 1
DI Record Publish Date: September 12, 2023