LIFESAVER HD-5468

GUDID 44710810093058

RESUS NEO W/ TUBE RSVR MASK

GaleMed Xiamen Co., Ltd.

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 44710810093058
• NIH Device Record Key: dd65afd4-dd08-43d6-ba85-203b07c9c706
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIFESAVER
• Version Model Number: 5468
• Catalog Number: HD-5468
• Company DUNS: 527333326
• Company Name: GaleMed Xiamen Co., Ltd.
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04710810093050 [Primary]
GS1	44710810093058 [Package]; Contains: 04710810093050; Package: Carton [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082092

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: 2015-09-19

On-Brand Devices [LIFESAVER]

• 44710810093102: RESUS ADULT W/FILTER AND MASK
• 44710810093096: RESUS ADULT W/TUBE RSVR AND MASK
• 44710810093089: RESUS ADULT W/TUBE RSVR FILTER
• 44710810093072: RESUS ADULT W/ MANOMETER FLTR
• 44710810093065: RESUS ADULT W/TUBE MANOMETER FLTR
• 44710810093058: RESUS NEO W/ TUBE RSVR MASK
• 44710810093041: RESUS NEO W/ TUBE MANMTR MASK
• 44710810093034: RESUS NEO MANOMETER AND MASK
• 44710810093027: RESUS PEDS W/ TUBE RSVR MASK
• 44710810093010: RESUS PEDS W/ TUBE MANMTR MASK
• 44710810093003: RESUS PEDS MANOMETER AND MASK
• 04710810093234: MANUAL RESUSCITATOR,DURABLE INFANT W/MASK
• 04710810093227: MANUAL RESUSCITATOR,DURABLE CHILD W/MASK
• 04710810093210: MANUAL RESUSCITATOR,DURABLE ADULT W/MASK
• 04710810093203: MANUAL RESUSCITATOR,DURABLE, INFANT
• 04710810093197: MANUAL RESUSCITATOR,DURABLE CHILD