Giraffe Stand-alone Infant Resuscitation System

GUDID 00840682100175

DATEX-OHMEDA INC

Pulmonary resuscitator, pneumatic, reusable

• Primary Device ID: 00840682100175
• NIH Device Record Key: 811fb85e-b5e4-467e-8f49-a36cd870b2fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Giraffe Stand-alone Infant Resuscitation System
• Version Model Number: Bag and Mask
• Company DUNS: 080887689
• Company Name: DATEX-OHMEDA 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: false
• Lot Batch: false
• Serial Number: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682100175 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070247

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: 2018-07-06
• Device Publish Date: 2015-09-23

On-Brand Devices [Giraffe Stand-alone Infant Resuscitation System]

• 00840682100175: Bag and Mask
• 00840682100151: T-piece