AccessGUDID - DEVICE: Vial Adaptor (07290108240245)

GUDID

Device Identifier (DI) Information

Brand Name: Vial Adaptor
Version or Model: 8070202
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WEST PHARMA. SERVICES IL, . LTD

Primary DI Number: 07290108240245
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600267793 *Terms of Use

Device Description: Vial Adapter 13mm Long w/25μm Filter- VF

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:	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, non-hermetic	A sterile device intended to be fitted to a vial or bottle to enable the removal of its contents, (e.g., medication, nutritional solution for enteral feeding) into a syringe, for subsequent administration to a patient. It is typically a housing with a syringe connector that attaches to the container or replaces its lid; it does not allow for pressure equalization/airtight transfer of contents. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Vial/bottle adaptor, non-hermetic

A sterile device intended to be fitted to a vial or bottle to enable the removal of its contents, (e.g., medication, nutritional solution for enteral feeding) into a syringe, for subsequent administration to a patient. It is typically a housing with a syringe connector that attaches to the container or replaces its lid; it does not allow for pressure equalization/airtight transfer of contents. 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 [?]
K963583	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

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: 14d1bcab-f0bc-44d4-a895-12f7dee35f28
Public Version Date: February 13, 2019
Public Version Number: 4
DI Record Publish Date: May 01, 2016