AccessGUDID - DEVICE: Vial Adapter MEDIC'UP (03701225770019)

GUDID

Device Identifier (DI) Information

Brand Name: Vial Adapter MEDIC'UP
Version or Model: Ø20mm filter 5µm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1MVA0008
Company Name: UNION PLASTIC

Primary DI Number: 03701225770019
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 381128396 *Terms of Use

Device Description: Sterile Vial Adapter Use for the transfer and mixing of drugs contained in vials.

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?
41222	Medication transfer set	A collection of sterile devices and supplies designed to transfer parenteral medications, and sometimes intravenous (IV) fluids, between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it may also be used to reconstitute medication for its preparation and administration. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. 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 [?]
K190149	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

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cf8e62ac-534a-4626-ab38-b57385e3316e
Public Version Date: March 15, 2024
Public Version Number: 1
DI Record Publish Date: March 07, 2024