TRUWAVE X 2 (3 CC) /VAMP 78 IN (200 CM) T005049B

GUDID 57460691949282

Invasive-pressure external transducer, single-use

Primary Device ID	57460691949282
NIH Device Record Key	77e7d0ad-20a6-4e06-881e-481bff7c3f9b
Commercial Distribution Status	In Commercial Distribution
Brand Name	TRUWAVE X 2 (3 CC) /VAMP 78 IN (200 CM)
Version Model Number	T005049B
Catalog Number	T005049B
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	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

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 Issuing Agency	Device ID
GS1	07460691949287 [Primary]
GS1	57460691949282 [Package] Contains: 07460691949287 Package: Case [10 Units] In Commercial Distribution

DXO	Transducer, Pressure, Catheter Tip

Steralize Prior To Use	false
Device Is Sterile	true

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50690103019242 - DISPOSABLE HANDLE FOR VALVES/SIZERS	2024-10-28 DISPOSABLE HANDLE FOR VALVES/SIZERS
00690103019339 - HEART VALVE ACCESSOR	2024-10-28 HANDLE,F/USE W/C-E PHYSIO RING MODEL 4450 N/S
00690103166989 - HEART VALVE ACCESSOR	2024-10-28 MITRAL SIZER HANDLE
00690103177701 - A HANDLE COMPATIBLE WITH RING HOLDERS MODELS 5100, 4900, 4100, 4200, 4450 AND 46	2024-10-28 RING HANDLE - EXTENDED 4"
00690103186437 - FLEXIBLE HANDLE	2024-10-28 FLEXIBLE HANDLE
00690103210132 - MITRIS Handle 1140M	2024-10-28 11400M valve handle
00690103217773 - Edwards EVOQUE Loading System	2024-10-11 Edwards EVOQUE Loading System