AccessGUDID - DEVICE: GO IO Intraosseous Start Kit 12/Case (M689GOIO010)

GUDID

Device Identifier (DI) Information

Brand Name: GO IO Intraosseous Start Kit 12/Case
Version or Model: 01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: GO IO
Company Name: Safeguard US Operating, LLC

Primary DI Number: M689GOIO010
Issuing Agency: HIBCC
Commercial Distribution End Date: December 12, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 118492643 *Terms of Use

Device Description: Secure IV and NIO Fixation

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:	Yes
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?
32172	Intravenous line stopcock	A sterile valve that is typically a component of an intravenous (IV) administration set and designed to be manually-operated by healthcare staff to regulate the flow of intravenous solution delivered to a patient. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OJA	Intravenous Extension Tubing Set

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
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: e2c0f575-529a-4554-b89d-d2d7b6fb6480
Public Version Date: December 13, 2024
Public Version Number: 2
DI Record Publish Date: September 01, 2022