FERNO2

GUDID 00814940020062

BVM, Child, Single Patient Use

Spiracle Technology

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 00814940020062
• NIH Device Record Key: eeffbe96-fc22-4fe1-beb8-c99129cf1f41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FERNO2
• Version Model Number: T30532
• 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	00814940020062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031434

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-04-12

On-Brand Devices [FERNO2]

• 00814940021519: PEZO2 fingertip pulse oximeter
• 00814940021434: BVM, Adult, Silicone Reusable
• 00814940021427: BVM, Child, Silicone Reusable
• 00814940021410: BVM, Infant, Reusable Silicone
• 00814940020888: Silicone Cuffed Mask: Size 5
• 00814940020871: Silicone Cuffed Mask: Size 4
• 00814940020864: Silicone Cuffed Mask: Size 3
• 00814940020857: Silicone Cuffed Mask: Size 2
• 00814940020840: Silicone Cuffed Mask: Size 1
• 00814940020833: Silicone Cuffed Mask: Size 0
• 00814940020505: Collection Bottle With Large Bore Catheter
• 00814940020109: Wall-Mounted Blood Pressure Cuff
• 00814940020093: CPR Mask
• 00814940020079: BVM, Infant, Single Patient Use
• 00814940020062: BVM, Child, Single Patient Use
• 00814940020055: BVM, Adult, Single Patient Use
• 00814940020048: MVP Manual Aspirator