ACCLARENT BALLOON INFLATION DEVICE BID30

GUDID 30705031063574

ACCLARENT INFLATION DEVICE

ACCLARENT, INC.

Catheter/overtube balloon inflator, single-use

• Primary Device ID: 30705031063574
• NIH Device Record Key: 83094983-15f3-4beb-9535-b2b433714325
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCLARENT BALLOON INFLATION DEVICE
• Version Model Number: BID30
• Catalog Number: BID30
• Company DUNS: 361092450
• Company Name: ACCLARENT, 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: true
• 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

Customer Support Contacts

• Phone: +1(877)775-2789
• Email: xx@xx.xx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705031063570 [Primary]
GS1	30705031063574 [Package]; Contains: 10705031063570; Package: BOX [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052198

FDA Product Code

• LRC: INSTRUMENT, ENT MANUAL SURGICAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-10-01

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