FERNO2

GUDID 00814940020840

Silicone Cuffed Mask: Size 1

Spiracle Technology

Resuscitator face mask, reusable

• Primary Device ID: 00814940020840
• NIH Device Record Key: 6381422d-0712-4b2d-98b2-bf19b5c49dfe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FERNO2
• Version Model Number: T50550-01
• 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: false
• 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	00814940020840 [Primary]

FDA Product Code

• KGB: Mask, Oxygen, Non-Rebreathing

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-04-12

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• 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
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• 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