Infant Flow 11541-102
GUDID 20846446004363
PATIENT CKT/GEN ASSY,BX 20,INFANT FLOW 730
Carefusion Corporation
Respiratory oxygen therapy system| Primary Device ID | 20846446004363 |
| NIH Device Record Key | a8da789e-dbf0-42df-bb63-7a523dfae8e4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Infant Flow |
| Version Model Number | 11541-102 |
| Catalog Number | 11541-102 |
| Company DUNS | 830432451 |
| Company Name | Carefusion Corporation |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 20846446004363 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K031745
FDA Product Code
| BZD | Ventilator, Non-Continuous (Respirator) |
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 | 2017-06-28 |
On-Brand Devices [Infant Flow]
| 70846446005907 | Circuit /LP Gen/No Prongs/ F&P 730 & 850 (Box/20) |
| 70846446005891 | Circuit /LP Gen/No Prongs/ F&P 730 & 850 (Box/10) |
| 70846446004757 | BONNET 10 PACK SIZE 6 INFANT FLOW |
| 20846446004363 | PATIENT CKT/GEN ASSY,BX 20,INFANT FLOW 730 |
| 10846446063394 | Infant Flow Configured Mobile Stand |
| 10846446061895 | Infant Flow Ventilator (legacy) |
Trademark Results [Infant Flow]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INFANT FLOW 85256994 4224023 Live/Registered |
Vyaire Medical Capital LLC 2011-03-03 |
INFANT FLOW 85256994 4224023 Live/Registered |
Vyaire Medical Capital LLC 2011-03-03 |
 INFANT FLOW 75445642 2526192 Live/Registered |
VYAIRE MEDICAL CAPITAL LLC 1998-03-06 |
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