Spiracle Technology - FERNO2 - DAN

GUDID 00814940021564

CPR Mask

Spiracle Technology

Cardiopulmonary resuscitation mask, single-use Cardiopulmonary resuscitation mask, single-use Cardiopulmonary resuscitation mask, single-use Cardiopulmonary resuscitation mask, single-use Cardiopulmonary resuscitation mask, single-use Cardiopulmonary resuscitation mask, single-use Cardiopulmonary resuscitation mask, single-use Cardiopulmonary resuscitation mask, single-use Cardiopulmonary resuscitation mask, single-use Cardiopulmonary resuscitation mask, single-use Cardiopulmonary resuscitation mask, single-use Cardiopulmonary resuscitation mask, single-use Cardiopulmonary resuscitation mask, single-use Cardiopulmonary resuscitation mask, single-use Cardiopulmonary resuscitation mask, single-use

• Primary Device ID: 00814940021564
• NIH Device Record Key: 2ebc3197-8f0c-478d-9a46-4cae3b4194e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spiracle Technology - FERNO2 - DAN
• Version Model Number: T50520
• Company DUNS: 836002451
• Company Name: Spiracle Technology
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814940021564 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171961

FDA Product Code

• KGB: Mask, Oxygen, Non-Rebreathing

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-19
• Device Publish Date: 2023-06-09

Devices Manufactured by Spiracle Technology

• 00814940021564 - Spiracle Technology - FERNO2 - DAN: 2023-06-19CPR Mask
• 00814940021564 - Spiracle Technology - FERNO2 - DAN: 2023-06-19 CPR Mask
• 00814940020185 - FERNO2 HFOC: 2019-07-12 HFOC valve, refill valve for use with Bag Valve Mask resuscitator.
• 00814940020048 - FERNO2: 2018-08-23 MVP Manual Aspirator
• 00814940020505 - FERNO2: 2018-08-23 Collection Bottle With Large Bore Catheter
• 00814940020055 - FERNO2: 2018-07-06 BVM, Adult, Single Patient Use
• 00814940020062 - FERNO2: 2018-07-06 BVM, Child, Single Patient Use
• 00814940020079 - FERNO2: 2018-07-06 BVM, Infant, Single Patient Use
• 00814940020109 - FERNO2: 2018-07-06 Wall-Mounted Blood Pressure Cuff