PHILIPS 989805616091
GUDID 00884838015838
Cfgkit,V60,NIST/Unifor,Whtfm,Cord:Schuko
Respironics California, Inc.
Portable electric ventilator| Primary Device ID | 00884838015838 |
| NIH Device Record Key | 2b0e6799-43c7-4e75-a855-aa9ffca90ec1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PHILIPS |
| Version Model Number | 1055579 |
| Catalog Number | 989805616091 |
| Company DUNS | 079550876 |
| Company Name | Respironics California, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884838015838 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K102985
FDA Product Code
| MNT | Ventilator, continuous, minimal ventilatory support, facility 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 | 2020-09-30 |
| Device Publish Date | 2020-09-22 |
On-Brand Devices [PHILIPS]
| 00884838050921 | KIT,O2 TRNSPORT,CART MNTG,DISS F |
| 00884838050402 | KIT,O2 TRANSPORT,CART MNTG,SIS |
| 00884838045248 | Kit,O2 Transport, Cart Mntg,NIST |
| 00884838045057 | O2 Cylinder holder, V680/V60 roll stand |
| 00884838045040 | V60 Stand Partially Assembled |
| 00884838045033 | V60 Stand Fully Assembled |
| 00884838044692 | KIT,O2 TRANSPORT,CART MTG,DISS-M |
| 00884838033832 | V60 VENT, JAPAN OPT: CFLEX,AVAPS,AT+ |
| 00884838028210 | Cable Assy, HIS/EMR Null Modem, V60/V680 |
| 00884838028203 | Cable Assy,HIS/EMR Modem, V60/V680 |
| 00884838025776 | V60 VENT, CHINA OPT: CFLEX, AVAPS |
| 00884838020429 | Assy Battery Li-Ion,11ah,V60 |
| 00884838015920 | Cfgkit,V60,NIST/Boc,Wht,Fm,Cord:UK |
| 00884838015913 | Cfgkit,V60,NIST/Din,Wht,Fm,Cord:Schuko |
| 00884838015906 | Cfgkit,V60,NIST/Aga,Wht,Fm,Cord:Schuko |
| 00884838015890 | Cfgkit,V60,NIST/Aga,Wht,Fm,Cord:Denmark |
| 00884838015883 | Cfgkit,V60,NIST,Wht,Ff,Cord:Swiss |
| 00884838015852 | Cfgkit,V60,DISS,Wht,Ff,Cord:UK |
| 00884838015845 | Cfgkit,V60,DISS,Grn,Ff,Cord:Italy |
| 00884838015838 | Cfgkit,V60,NIST/Unifor,Whtfm,Cord:Schuko |
| 00884838015821 | Cfgkit,V60,NIST/Unifor,Wht,Fm,Cord:Italy |
| 00884838015807 | Cfgkit,V60,NIST,Wht,Ff,Cord:SchUKo |
| 00884838015791 | Cfgkit,V60,DISS,Grn,Ff,Cord:UK |
| 00884838015753 | Cfgkit,V60,NIST/Afnor,Wht,Fm,Cord:Schuko |
| 00884838015739 | Cfgkit,V60,NIST,Wht,Ff,Cord:UK |
| 00884838015722 | Cfgkit,V60,DISS,Grn,Ff,Cord:Schuko |
| 00884838009868 | V60 Ventilator, Intl Opt: None |
| 00884838009851 | V60 Ventilator,Intl Opt: CFLEX,AVAPS |
| 00884838009844 | V60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV |
Trademark Results [PHILIPS]
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.