Mix2Vial Transfer Device

GUDID 27290108240812

Mix2Vial 13/13mm w/25μm Filter

WEST PHARMA. SERVICES IL, . LTD

Medication transfer needle, filtering

• Primary Device ID: 27290108240812
• NIH Device Record Key: 6eb704be-2f4d-4a92-b0e7-712b329dc0f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mix2Vial Transfer Device
• Version Model Number: 8074213
• Company DUNS: 600267793
• Company Name: WEST PHARMA. SERVICES IL, . LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290108240818 [Primary]
GS1	17290108240815 [Package]; Contains: 07290108240818; Package: [150 Units]; In Commercial Distribution
GS1	27290108240812 [Package]; Contains: 17290108240815; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031861

FDA Product Code

• LHI: Set, I.V. Fluid Transfer

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[27290108240812]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-03-18
• Device Publish Date: 2016-05-01

On-Brand Devices [Mix2Vial Transfer Device]

• 27290108240997: Mix2Vial™ 20/20mm w/15µm Large Filter TG
• 27290108240867: Mix2Vial™ 13/13mm
• 27290108240812: Mix2Vial 13/13mm w/25μm Filter
• 27290108240805: Mix2Vial 20/20 WR & 15mic L. filter-TG
• 27290108240768: Mix2Vial 20/17mm
• 27290108240690: Mix2Vial™ 20/20mm w/15µm Large Filter TG S-Spike
• 27290108240676: Mix2vial 20/20
• 27290108240546: Mix2vial 20/17mm with large filter
• 27290108240539: M2V 20/20mm w/5mic Filter
• 27290108240423: Mix2Vial 20/20mm W/20mic large filter TG S-Spike
• 27290108240409: Mix2Vial™ 20/17mm w/15μm Large Filter-TGW
• 27290108240393: Mix2Vial 20/17mm W/5mic Filter SIL
• 27290108240386: Mix2Vial 20/20mm 5mic filter TG S- Spike
• 27290108240379: Mix2vial 20/20 w/ 15mic large filter
• 27290108240263: M2V 20/20mm w/15mic large filter TG S- Spike