AccessGUDID - DEVICE: PINNACLE® (04046964957451)

GUDID

Device Identifier (DI) Information

Brand Name: PINNACLE®
Version or Model: 601212
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 601212
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04046964957451
Issuing Agency: GS1
Commercial Distribution End Date: March 14, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 002397347 *Terms of Use

Device Description: FINAL ASSY, CONTROL MODULE, TPN MANAGER

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:	No
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?
17459	Intravenous solution compounder	A device that is typically exclusively used in the clinical pharmacy or a manufacturing plant for the production of intravenous (IV) fluids. These fluids will typically be distributed using the appropriate containers.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NEP	SYSTEM/DEVICE, PHARMACY COMPOUNDING

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
Special Storage Condition, Specify:
Special Storage Condition, Specify: Fragile, handle with care

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 026e4c31-bf94-41e7-8a75-af39e1f4f5f7
Public Version Date: February 24, 2025
Public Version Number: 5
DI Record Publish Date: September 23, 2016