TRUWAVE T001657A
GUDID 57460691902041
PRESSURE MONITORING SET
Edwards Lifesciences LLC
Invasive-pressure external transducer, single-use| Primary Device ID | 57460691902041 |
| NIH Device Record Key | 8feeaacc-c986-4b61-b237-7ba8033f8eeb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRUWAVE |
| Version Model Number | T001657A |
| Catalog Number | T001657A |
| Company DUNS | 134139174 |
| Company Name | Edwards Lifesciences LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07460691902046 [Primary] |
| GS1 | 57460691902041 [Package] Contains: 07460691902046 Package: SHIPPER [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K171996
FDA Product Code
| DXO | Transducer, Pressure, Catheter Tip |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-08-31 |
| Device Publish Date | 2018-07-31 |
On-Brand Devices [TRUWAVE]
| 00690103197754 | PRESSURE MONITORING SET |
| 00690103197747 | PRESSURE MONITORING SET |
| 00690103197730 | PRESSURE MONITORING SET |
| 00690103196948 | CABLE ASSY, TRUWAVE EMAGEON |
| 00690103196863 | CABLE ASSY,EW,TRI,SPLBS |
| 00690103196856 | CABLE ASSY,EW,BI,SPLBS |
| 00690103196849 | CABLE ASSY, TRUWAVE |
| 00690103196832 | CABLE ASSY, TRUWAVE |
| 00690103196825 | CABLE ASSY,EW,TRI,GE,ROHS |
| 00690103196818 | CABLE ASSY,EW,BI,GE, ROHS |
| 00690103196795 | CABLE ASSY, TRUWAVE |
| 00690103196764 | CABLE ASSY,EW,TRI,DATEX |
| 00690103196757 | CABLE ASSY,EW,BI,DATEX |
| 00690103196740 | CABLE ASSY,EW,TRI,PHLPS |
| 00690103196733 | CABLE ASSY,EW,BI,PHLPS |
| 00690103196726 | CABLE ASSY, TRUWAVE |
| 00690103196719 | CABLE ASSY, TRUWAVE |
| 00690103196702 | CABLE ASSY, TRUWAVE |
| 00690103196696 | CABLE ASSY, TRUWAVE |
| 00690103196689 | CABLE ASSY,EW,TRI,DSCPE |
| 00690103196672 | CABLE ASSY,EW,BI,DSCPE |
| 00690103196665 | CABLE ASSY,TRUWAVE |
| 00690103196658 | CABLE ASSY, TRUWAVE |
| 00690103196641 | CABLE ASSY, TRUWAVE, ROHS |
| 00690103196634 | CABLE ASSY,TRUWAVE |
| 00690103196627 | CABLE ASSY,EW TRUWAVE |
| 00690103196610 | CABLE ASSY, TRUEWAVE |
| 00690103196603 | CABLE ASSEMBLY,EW |
| 00690103196597 | CABLE ASSY,TRUWAVE |
| 00690103196580 | CABLE ASSY, EW QUEST ANTEGRADE |
| 00690103196573 | CABLE ASSY,EW QUEST RETROGRADE |
| 00690103196566 | CABLE ASSY,EW TRUWAVE |
| 00690103196559 | CABLE, ADAPTER, JOSTRA |
| 00690103196542 | CABLE ASSY,EW TRUWAVE |
| 00690103196535 | CABLE ASSY,EW TRUWAVE |
| 00690103196528 | CABLE ASY,EW HELLIGE 6 PIN PPG |
| 00690103196511 | CABLE ASSY,EW 10 PIN/DRAGER |
| 00690103196504 | CABLE ASSY,TRUWAVE |
| 00690103196498 | CABLE ASSY,EW PRUCKA |
| 00690103196481 | CBL ASY,EW 12 PN/FUKUDA DENSHI |
| 00690103196474 | CBL ASSY,MARQUETTE/RCTN,ROHS |
| 00690103196467 | CBL ASSY,MARQUETTE/RCTN,ROHS |
| 00690103196450 | CBL ASSY,MARQUETTE/RCTN,ROHS |
| 00690103196443 | CBL ASSY,MARQUETTE/RCTN,ROHS |
| 00690103196436 | CABLE ASSY, TRUWAVE |
| 00690103196429 | CABLE ASSY, TRUWAVE |
| 00690103196412 | CABLE ASSY,EW TRUWAVE |
| 00690103196405 | CABLE ASSY,EW SIEMENS, ROHS |
| 00690103196399 | CABLE ASSY, EW SIEMENS, ROHS |
| 00690103196382 | CABLE ASSY,EW SIMPLE |
Trademark Results [TRUWAVE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRUWAVE 88685559 not registered Live/Pending |
LEDVANCE LLC 2019-11-08 |
 TRUWAVE 85228329 4113928 Live/Registered |
Edwards Lifesciences Corporation 2011-01-27 |
 TRUWAVE 77953073 4046121 Live/Registered |
ROTOR CLIP COMPANY, INC. 2010-03-08 |
 TRUWAVE 74632798 2154001 Dead/Cancelled |
EDWARDS LIFESCIENCES CORPORATION 1995-02-10 |
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