AccessGUDID - DEVICE: Medline ReNewal (10888277188648)

GUDID

Device Identifier (DI) Information

Brand Name: Medline ReNewal
Version or Model: N2FOURPORTR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N2FOURPORTR
Company Name: MEDLINE INDUSTRIES, INC.

Primary DI Number: 10888277188648
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 025460908 *Terms of Use

Device Description: MANIFOLD, FOUR PORT, NEP2, REPROCESSED

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?
36271	Medical gas/vacuum pipeline system	An assembly of devices comprising a medical gas/vacuum pipeline system designed to supply compressed medical gases [oxygen (O2), nitrous oxide (N2O), medical air, surgical-grade air] and vacuum from a central source to outlets and/or inlets throughout a medical facility. A system may consist of a gas supply, vacuum pump and tank, manifold unit, a pressure regulation and alarm system, a pipework system, remote or local indicators, pressure relief valves, zone shut off valves, and wall outlet terminal units.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYZ	TRAP, STERILE SPECIMEN

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
Outer Diameter: 1.94 Inch

Device Record Status

Public Device Record Key: b8607e1b-6dc8-4faf-b5fa-9b7e8ee90c19
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 14, 2016