Acumen IQ Sensor with Fluid Meter AIQSFM85

GUDID 50690103205805

Electronic gravity infusion controller

Primary Device ID	50690103205805
NIH Device Record Key	b41e0681-e6a3-4709-940b-390f9a37a0b9
Commercial Distribution Status	In Commercial Distribution
Brand Name	Acumen IQ Sensor with Fluid Meter
Version Model Number	AIQSFM85
Catalog Number	AIQSFM85
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	00690103205800 [Primary]
GS1	50690103205805 [Package] Contains: 00690103205800 Package: Shipper [5 Units] In Commercial Distribution

DQK	Computer, Diagnostic, Programmable

Steralize Prior To Use	false
Device Is Sterile	true

00690103217278 - Edwards	2025-01-15 Edwards Reusable Plate
00690103217292 - Edwards	2025-01-15 Edwards Reusable Platform
00690103218015 - Edwards	2025-01-15 Edwards Reusable Cradle
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"