AccessGUDID - DEVICE: MP Vial Adapter 13 mm (37290108240574)

GUDID

Device Identifier (DI) Information

Brand Name: MP Vial Adapter 13 mm
Version or Model: 8070149
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: WEST PHARMA. SERVICES IL, . LTD

Primary DI Number: 37290108240574
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 600267793 *Terms of Use

Device Description: MP Vial Adapter 13mm FLL – VF 3 Pack

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?
60539	Vial/bottle adaptor, non-hermetic	A 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 barbed connection or spike that attaches to or replaces the container lid, and a small bore connection (typically ENFit or a Luer); it does not allow for pressure equalization/airtight transfer of contents. 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 [?]
K130179	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: c8a318b1-9e8c-43c4-8649-2970fff9809b
Public Version Date: February 03, 2022
Public Version Number: 8
DI Record Publish Date: May 01, 2016