AccessGUDID - DEVICE: DUAL LEAD HIGH VOLUME PUMP CHAMBER SET (00810080610569)

GUDID

Device Identifier (DI) Information

Brand Name: DUAL LEAD HIGH VOLUME PUMP CHAMBER SET
Version or Model: 2 PHARM-6
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MPS Pharma & Medical, Inc.

Primary DI Number: 00810080610569
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117970217 *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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
41646	Compounding transfer set	A collection of sterile items typically used in the clinical pharmacy or a manufacturing plant to provide a sterile fluid path for the compounding (mixing) of different multi-ingredient solutions from multiple source containers into a final suitable container. It is typically available in a variety of configurations (e.g., as a 6-lead or a 9-lead set) and includes, e.g., tubes, connectors, spikes. This device may also be used for intravenous (IV) solution compounding. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NEP	System/Device, Pharmacy Compounding
JTB	Device, Media Dispensing/Stacking

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: 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: 28e51d2c-a4c8-4e9f-9fbd-7632b1879752
Public Version Date: September 01, 2022
Public Version Number: 1
DI Record Publish Date: August 24, 2022