AccessGUDID - DEVICE: Summit International (B346R0021)

GUDID

Device Identifier (DI) Information

Brand Name: Summit International
Version or Model: R002
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: R002
Company Name: DRAGON HEART MEDICAL, INC.

Primary DI Number: B346R0021
Issuing Agency: HIBCC
Commercial Distribution End Date: April 30, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 841522985 *Terms of Use

Device Description: Product consist of piercing spike and cover, the twist off-connector and an integrated vial adaptor for access to drugs/solution vials. Indicated to serve as a connecting port between IV bag and external IV line.

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):	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?
36244	Electronic gravity infusion controller administration set	A collection of devices designed for the intravenous (IV) administration of fluid from a container, through an automated infusion controller, to a catheter/needle hub or extension tube set at the patient site. The collection typically consists of plastic tubing, a check valve, a roller clamp, a Y-piece connector for secondary tubing attachment, and Luer connectors at both ends. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FPA	Set, Administration, Intravascular

FDA Premarket Submission

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

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: a164fc6f-6794-4da6-b9b4-cf8039b5f13b
Public Version Date: April 30, 2024
Public Version Number: 3
DI Record Publish Date: May 03, 2021