AccessGUDID - DEVICE: OnGuard 2 CSTD IV Secondary Safety Set with ULTRASITE (37290115921404)

GUDID

Device Identifier (DI) Information

Brand Name: OnGuard 2 CSTD IV Secondary Safety Set with ULTRASITE
Version or Model: 412140
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SIMPLIVIA HEALTHCARE LTD

Primary DI Number: 37290115921404
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 521161349 *Terms of Use

Device Description: A Chemfort CSTD Product

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 [?]
K201142	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: 9fc24a37-a655-42e6-8204-ec27a3798d2a
Public Version Date: March 19, 2021
Public Version Number: 1
DI Record Publish Date: March 11, 2021