AccessGUDID - DEVICE: MaxPlus (10885403237300)

GUDID

Device Identifier (DI) Information

Brand Name: MaxPlus
Version or Model: MPX9104
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MPX9104
Company Name: BD Switzerland Sàrl

Primary DI Number: 10885403237300
Issuing Agency: GS1
Commercial Distribution End Date: February 01, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 482631558 *Terms of Use

Device Description: 7.5 IN MINIBORE EXTENSION SET W/MAX Y

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
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
Special Storage Condition, Specify: Room Temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2409a5bb-856b-4ed0-a1e0-22ad5da28f21
Public Version Date: July 23, 2024
Public Version Number: 6
DI Record Publish Date: November 04, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20885403237307	600	10885403237300	2023-02-01	Not in Commercial Distribution	Case
50885403237308	50	10885403237300	2023-02-01	Not in Commercial Distribution	Shelfpack