Boundtree DS101

GUDID 40260720000195

Disp Bag Mask Resus, Bound Tree Adult Configuration

ALLIED HEALTHCARE PRODUCTS, INC.

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 40260720000195
• NIH Device Record Key: 437d3de6-254b-4fcb-b4fd-63f0d9e2f644
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Boundtree
• Version Model Number: DS101
• Catalog Number: DS101
• 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	00026072000199 [Primary]
GS1	00260720000197 [Primary]
GS1	40260720000195 [Package]; Contains: 00026072000199; 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 [Boundtree]

• 40260720000195: Disp Bag Mask Resus, Bound Tree Adult Configuration
• 00026072000199: Disp Bag Mask Resus, Bound Tree Adult Configuration