Rescuer 4000F
GUDID B0024000F0
HEPA Filter component for Rescuer BVM Manual Resuscitator (Emergency Manual Ventilator)
B.L.S. Systems Limited
Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use| Primary Device ID | B0024000F0 |
| NIH Device Record Key | f85d23bf-ec2d-4b84-9dc1-b4cf7752945c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rescuer |
| Version Model Number | 4000F |
| Catalog Number | 4000F |
| Company DUNS | 200103823 |
| Company Name | B.L.S. Systems Limited |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B0024000F0 [Primary] |
| HIBCC | B0024000F2 [Package] Package: Bag [10 Units] In Commercial Distribution |
| HIBCC | B0024000F3 [Package] Package: Bag [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K993194
FDA Product Code
| BTM | Ventilator, Emergency, Manual (Resuscitator) |
| CAH | Filter, Bacterial, Breathing-Circuit |
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 | 2021-01-18 |
| Device Publish Date | 2021-01-08 |
On-Brand Devices [Rescuer]
| B0024000F0 | HEPA Filter component for Rescuer BVM Manual Resuscitator (Emergency Manual Ventilator) |
| B0023000X7 | Rescuer CPR Shield with gloves |
| B0024050RB7 | Replacement reservoir bag (2.9L) for 4000 series manual resuscitator |
Trademark Results [Rescuer]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RESCUER 79253422 not registered Live/Pending |
VALEO SERVICE 2018-10-18 |
 RESCUER 78715112 not registered Dead/Abandoned |
Everlap Limited 2005-09-17 |
 RESCUER 74625926 2010994 Dead/Cancelled |
POLLENEX CORPORATION 1995-01-26 |
 RESCUER 74305725 1761038 Dead/Cancelled |
Consolidated Cotton Gin Co., Inc. 1992-08-20 |
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