AccessGUDID - DEVICE: INTERLINK (00085412004976)

GUDID

Device Identifier (DI) Information

Brand Name: INTERLINK
Version or Model: 2N3395
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2N3395
Company Name: BAXTER INTERNATIONAL INC.

Primary DI Number: 00085412004976
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005146311 *Terms of Use

Device Description: Universal Vial Adapter

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
Vial/bottle adaptor, hermetic	A sterile device intended to be fitted to a vial or bottle to enable the airtight removal of its contents (e.g., medication) into a syringe, for subsequent administration to a patient. It is typically a housing that attaches to or replaces the vial lid and incorporates a sealed expansion chamber (e.g., balloon) allowing for pressure equalization intended to prevent the egress and ingress of materials (e.g., vapours, microbes). This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Vial/bottle adaptor, hermetic

A sterile device intended to be fitted to a vial or bottle to enable the airtight removal of its contents (e.g., medication) into a syringe, for subsequent administration to a patient. It is typically a housing that attaches to or replaces the vial lid and incorporates a sealed expansion chamber (e.g., balloon) allowing for pressure equalization intended to prevent the egress and ingress of materials (e.g., vapours, microbes). This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
LHI	Set, i.V. Fluid transfer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K924064	000

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

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d0b1e60c-e55f-4a84-82a7-90e4fc79fd79
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016