AccessGUDID - DEVICE: B.BRAUN (04046964656101)

GUDID

Device Identifier (DI) Information

Brand Name: B.BRAUN
Version or Model: 2112550
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2112550
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04046964656101
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 002397347 *Terms of Use

Device Description: APEX 26- LEAD TRANSFER SET

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

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

GMDN Preferred Term Name	GMDN Definition
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.

GMDN Preferred Term Name

GMDN Definition

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.

FDA Product Code

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Product Code	Product Code Name
NEP	SYSTEM/DEVICE, PHARMACY COMPOUNDING
LHI	Set, i.V. Fluid transfer

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

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Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 57bbbe8c-9fb8-4d50-b5d4-179d81221b60
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016