AccessGUDID - DEVICE: Swabable Vented Vial Adapter (07290108240917)

GUDID

Device Identifier (DI) Information

Brand Name: Swabable Vented Vial Adapter
Version or Model: 8073021
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: WEST PHARMA. SERVICES IL, . LTD

Primary DI Number: 07290108240917
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 13mm 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?
60822	Medication transfer needle, filtering/vented	A slender, rigid, sharp or blunt, dual-lumen tube intended to be attached to a syringe and typically used in the pharmacy to aspirate and transfer fluid medication from a vial/ampule to another container for medication preparation or other purposes. It is designed to puncture the vial septum, aspirate medication and simultaneously allow air into the vial to reduce back-pressure; it has an integral filter intended to prevent the ingress of airborne microbial contaminants. Typically, the proximal end is a Luer connector. The device is sometimes referred to as vent spike. 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: 5bfbbb53-7287-4af3-90be-8317a05349d8
Public Version Date: June 30, 2023
Public Version Number: 7
DI Record Publish Date: May 01, 2016