AccessGUDID - DEVICE: Line (00817984011041)

GUDID

Device Identifier (DI) Information

Brand Name: Line
Version or Model: 0600-2152-000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0600-2152-000
Company Name: MECTRA LABS, INC.

Primary DI Number: 00817984011041
Issuing Agency: GS1
Commercial Distribution End Date: January 10, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 606939072 *Terms of Use

Device Description: Dual Spike Saline

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?
41978	Surgical irrigation/aspiration system	An assembly of devices used to intermittently or continuously irrigate and/or aspirate body cavities and wounds during a general surgical procedure. It provides for the removal of loose tissue, fluids, and other debris to keep the surgical site clear, helping to optimize visualization and access. The assembly typically includes a mains electricity (AC-powered) pump, collection bottles, tubing, and connectors. It may be used together with an irrigation catheter. It is not intended to be used for the administration of parenteral fluids, infusion of drugs, or for any life sustaining purposes.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GBX	CATHETER, IRRIGATION

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
Handling Environment Temperature: between 20 and 115 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e2c6f71d-c7a8-437f-88f4-aeacaa0c36b8
Public Version Date: January 13, 2020
Public Version Number: 2
DI Record Publish Date: January 29, 2019