FDA UDI
In Commercial Distribution
🇺🇸 United States
Acumen IQ Sensor with Fluid Meter
DI: 00690103205800
·
Model: AIQSFM85
·
Edwards Lifesciences LLC
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Acumen IQ Sensor with Fluid Meter
- Primary DI
- 00690103205800
- Version / Model
- AIQSFM85
- Catalog Number
- AIQSFM85
- Company Name
- Edwards Lifesciences LLC
- Labeler DUNS
- 134139174
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-28
- Public Version
- 1
- Public Version Date
- 2023-08-07
- Public Version Status
- New
- Public Device Record Key
- b41e0681-e6a3-4709-940b-390f9a37a0b9
Device Description
ACUMEN IQ SENSOR 84'' / 213CM WITH FLUID METER 5-PACK
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | Cardiovascular | 870.1425 | 2 |
| QMS | Adjunctive Open Loop Fluid Therapy Recommender | Cardiovascular | 870.5600 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11010 | Electronic gravity infusion controller | An electrically-powered device intended to be used to control and monitor the gravity infusion of intravenous (IV) fluids, providing an alarm (visible/audible) when pre-set limits are exceeded. It is available in two main configurations: 1) a device with an electronic flow sensor (drop counter) that monitors/measures the amount of fluid that passes through the infusion line; or 2) a device that measures the weight of the fluid container and may assist in bolus administration. The predetermined values may be selected by the user, and the device may display flow rate, total volume, and may record data. Some types can be used during arthroscopic procedures. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50690103205805 | GS1 | Shipper | 5 | In Commercial Distribution | |
| Primary | 00690103205800 | GS1 |
Customer Contacts
- Phone
- +1(800)822-9837
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry place.