AccessGUDID - DEVICE: PINNACLE® (04046964200823)

GUDID

Device Identifier (DI) Information

Brand Name: PINNACLE®
Version or Model: 2112351
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2112351
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04046964200823
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 002397347 *Terms of Use

Device Description: PINNACLE® Single Chamb er Mixing Container, EVA Formulation, 4000 mL

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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Parenteral/enteral solution bag	A flexible pouch or sack designed to contain a solution of nutrients or medication for administration to a patient either parenterally (e.g., intravenously) or enterally (directly into the gastrointestinal tract). It is typically made of synthetic polymer materials. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
KPE	CONTAINER, I.V.

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 416c233e-36cf-4a19-9f86-6635cb0d9493
Public Version Date: April 03, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016