Life2000
GUDID 00887761978089
LIFE2000 VENTILATOR
WELCH ALLYN, INC.
Portable pneumatic ventilator| Primary Device ID | 00887761978089 |
| NIH Device Record Key | c9827e80-e861-4f94-8e3b-845dedcb59ca |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Life2000 |
| Version Model Number | MS-01-0118 |
| Company DUNS | 198227881 |
| Company Name | WELCH ALLYN, 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 | 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887761978089 [Primary] |
| GS1 | 00887761981638 [Package] Package: [1 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K170037
FDA Product Code
| NOU | Continuous, ventilator, home use |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-17 |
| Device Publish Date | 2024-05-09 |
Devices Manufactured by WELCH ALLYN, INC.
| 00732094214154 - Welch Allyn, Inc. | 2024-11-11 VS100 UDI BASE UNIT |
| 00732094214475 - Welch Allyn, Inc. | 2024-11-01 CUFF NEO 1 DISP 2 TUBE NON LUER W CLAMP |
| 00732094214468 - Welch Allyn, Inc. | 2024-11-01 CUFF NEO 2 DISP 2 TUBE NON LUER W CLAMP |
| 00732094214451 - Welch Allyn, Inc. | 2024-11-01 CUFF NEO 3 DISP 2 TUBE NON LUER W CLAMP |
| 00732094214444 - Welch Allyn, Inc. | 2024-11-01 CUFF NEO 4 DISP 2 TUBE NON LUER W CLAMP |
| 00732094230826 - Welch Allyn, Inc. | 2024-11-01 CIWS WRLS NEL SCS IRT |
| 00732094230857 - Welch Allyn, Inc. | 2024-11-01 CIWS WRLS NEL SCS |
| 00732094231014 - Welch Allyn, Inc. | 2024-11-01 CIWS WRLS MAS SCS |
Trademark Results [Life2000]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LIFE2000 86336763 5418518 Live/Registered |
BREATHE TECHNOLOGIES, INC. 2014-07-14 |
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