AccessGUDID - DEVICE: 16 in. (38 cm) Q2 Checkmate extension set (00634624954809)

GUDID

Device Identifier (DI) Information

Brand Name: 16 in. (38 cm) Q2 Checkmate extension set
Version or Model: 9548
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9548
Company Name: QUEST MEDICAL INC

Primary DI Number: 00634624954809
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041810693 *Terms of Use

Device Description: No description.

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?
12170	Intravenous administration tubing extension set	A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPK	Tubing, Fluid Delivery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162304	000
K800825	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: 58711058-603c-4874-a416-5a8722387963
Public Version Date: July 06, 2018
Public Version Number: 2
DI Record Publish Date: May 22, 2018