AccessGUDID - DEVICE: OnGuard Spike Port Adaptor (37290115921138)

GUDID

Device Identifier (DI) Information

Brand Name: OnGuard Spike Port Adaptor
Version or Model: 412113
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SIMPLIVIA HEALTHCARE LTD

Primary DI Number: 37290115921138
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 521161349 *Terms of Use

Device Description: The Spike Port Adaptor is part of the OnGuard CSTD system. The devices spike connects to IV solution container. The proximal end connects to IV set spike, to allow administration. The port connects to OnGuard2 Syringe Adaptor to transfer drug or withdraw saline / drug.

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 [?]
K141448	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: fe6ea7b9-523b-408a-a3eb-5f679893fb1b
Public Version Date: October 11, 2022
Public Version Number: 1
DI Record Publish Date: October 03, 2022