FlowEase [Subcutaneous] Infusion Set 1M2012

GUDID 50642621029258

BAXALTA US INC.

Subcutaneous injection/infusion port needle Subcutaneous injection/infusion port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle

• Primary Device ID: 50642621029258
• NIH Device Record Key: f400f162-9c39-454e-a81e-339fe3507628
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlowEase [Subcutaneous] Infusion Set
• Version Model Number: 1M2012
• Catalog Number: 1M2012
• Company DUNS: 079887619
• Company Name: BAXALTA US INC.
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Needle Gauge: 24 Gauge
• Needle Gauge: 24 Gauge
• Needle Gauge: 24 Gauge
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge
• Length: 12 Millimeter
• Needle Gauge: 24 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00642621029253 [Primary]
GS1	20642621029257 [Package]; Contains: 00642621029253; Package: Intermediate [12 Units]; In Commercial Distribution
GS1	50642621029258 [Package]; Contains: 20642621029257; Package: Shipper [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121092

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-28

On-Brand Devices [FlowEase [Subcutaneous] Infusion Set]

• 50642621029258: 1M2012
• 50642621029241: 1M2009
• 50642621029234: 1M2006