EDWARDS SAPIEN 3 PULMONIC DELIVERY SYSTEM (29MM) 9630PL29A

GUDID 00690103210873

Pulmonary transcatheter heart valve bioprosthesis

Primary Device ID	00690103210873
NIH Device Record Key	d4e073af-1e81-427e-843f-fa58a34d7eff
Commercial Distribution Status	In Commercial Distribution
Brand Name	EDWARDS SAPIEN 3 PULMONIC DELIVERY SYSTEM (29MM)
Version Model Number	9630PL29A
Catalog Number	9630PL29A
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
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	00690103210873 [Primary]

NPV	Pulmonary Valve Prosthesis Percutaneously Delivered

Steralize Prior To Use	false
Device Is Sterile	true

00690103019063 - HEART VALVE HANDLE ACCESSORY	2024-10-28 HDLE,MITRAL ST/STEEL F/USE W/ 6625 OR 9120R HEART VLV
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