Bound Tree DS103

GUDID 40260720000218

Disp Bag Mask Resus, Bound Tree, Infant Configuration

ALLIED HEALTHCARE PRODUCTS, INC.

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 40260720000218
• NIH Device Record Key: a8b3e25f-39e9-4939-994d-09685ac4add5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bound Tree
• Version Model Number: DS103
• Catalog Number: DS103
• Company DUNS: 099674145
• Company Name: ALLIED HEALTHCARE PRODUCTS, 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: false
• 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	00026072000212 [Primary]
GS1	00260720000210 [Primary]
GS1	40260720000218 [Package]; Contains: 00026072000212; Package: Case [16 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K014071

FDA Product Code

• BTM: Ventilator, Emergency, Manual (Resuscitator)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-13
• Device Publish Date: 2015-12-09

On-Brand Devices [Bound Tree]

• 40260720000218: Disp Bag Mask Resus, Bound Tree, Infant Configuration
• 40260720000201: Disp Bag Mask Resus, Bound Tree, Child Configuration
• 00026072000212: Disp Bag Mask Resus, Bound Tree, Infant Configuration
• 00026072000205: Disp Bag Mask Resus, Bound Tree, Child Configuration