LIVESAVER 5340
GUDID 24710810093184
MANUAL RESUSCITATOR, DURABLE, ADULT
GaleMed Xiamen Co., Ltd.
Pulmonary resuscitator, manual, reusable| Primary Device ID | 24710810093184 |
| NIH Device Record Key | 88766cc7-d5ab-43c4-8106-db9a4f24bc8b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LIVESAVER |
| Version Model Number | HD-5340 |
| Catalog Number | 5340 |
| 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 | false |
| 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 |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04710810093180 [Direct Marking] |
| GS1 | 24710810093184 [Primary] |
| GS1 | 44710810093188 [Package] Package: Carton [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K895589
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 | 2016-09-28 |
Devices Manufactured by GaleMed Xiamen Co., Ltd.
| 46923980115552 - Mindray | 2025-07-01 Silicone Breathing Bag, 2L |
| 46923980100558 - Ambu | 2025-06-09 Open Cuff Silicone Face Mask Reusable Face Mask #0 |
| 46923980100565 - Ambu | 2025-06-09 Open Cuff Silicone Face Mask Reusable Face Mask #1 |
| 46923980100572 - Ambu | 2025-06-09 Open Cuff Silicone Face Mask Reusable Face Mask #2 |
| 46923980100589 - Ambu | 2025-06-09 Open Cuff Silicone Face Mask Reusable Face Mask #3 |
| 46923980100596 - Ambu | 2025-06-09 Open Cuff Silicone Face Mask Reusable Face Mask #4 |
| 46923980100602 - Ambu | 2025-06-09 Open Cuff Silicone Face Mask Reusable Face Mask #5 |
| 46923980104273 - N/A | 2024-12-05 Theta Circuit, 180cm |
Trademark Results [LIVESAVER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LIVESAVER 85342695 not registered Dead/Abandoned |
Life Paint Company, Inc. 2011-06-09 |
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