AccessGUDID - DEVICE: Swabable Vented Vial Adapter (07290108240740)

GUDID

Device Identifier (DI) Information

Brand Name: Swabable Vented Vial Adapter
Version or Model: 8073011
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: WEST PHARMA. SERVICES IL, . LTD

Primary DI Number: 07290108240740
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 600267793 *Terms of Use

Device Description: Swabable Vial Adapter 20mm with Vented Spike –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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60537	Vial/bottle adaptor, hermetic	A 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 with a spike that attaches to or replaces the container lid, plus a Luer connection and 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LHI	Set, I.V. Fluid Transfer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K072511	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Ethylene Oxide

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: 19d48418-b6b1-448f-bd56-17e9293938bf
Public Version Date: June 30, 2023
Public Version Number: 7
DI Record Publish Date: May 01, 2016