AccessGUDID - DEVICE: PINNACLE® (04046964200823)

GUDID

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

Primary DI Number: 04046964200823
Issuing Agency: GS1
Device Count: 5

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

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 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.

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

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling
No storage/handling found

Size Type Text
No Device Sizes

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 23, 2016
Commercial Distribution End Date:

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
04046964200830	4	04046964200823		In Commercial Distribution	Carton

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI Number: 04046964231766 CLOSE

Device Subject to Direct Marking (DM), but Exempt: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Phone: +1(800)848-2066
Email: rtd.us@bbraun.com