AccessGUDID - DEVICE: VA 13mm with Silicon (07290108241105)

GUDID

Device Identifier (DI) Information

Brand Name: VA 13mm with Silicon
Version or Model: 8070314
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WEST PHARMA. SERVICES IL, . LTD

Primary DI Number: 07290108241105
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600267793 *Terms of Use

Device Description: No description.

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 [?]
K001293	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: 31b2afa2-68f7-49dd-9727-8b01b980a17d
Public Version Date: June 23, 2023
Public Version Number: 1
DI Record Publish Date: June 15, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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