FDA UDI
In Commercial Distribution
🇺🇸 United States
ClearLine MD
DI: 00863193000338
·
Model: Part#:2126
·
ANESTHESIA SAFETY PRODUCTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ClearLine MD
- Primary DI
- 00863193000338
- Version / Model
- Part#:2126
- Company Name
- ANESTHESIA SAFETY PRODUCTS, LLC
- Labeler DUNS
- 364188032
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 2426cd91-c021-45e8-a299-37d8dd98bbc1
Device Description
ClearLine IV, (the new product name of AirPurge System - Control Unit), is intended for detection and automatic removal of air in intravenous lines during administration of intravenous solutions, blood and blood products. It is indicated for use in the Operating Room and post anesthesia care areas. The ClearLine IV is placed distal to I.V. bags using gravity feed or pressure, and may be used with or without fluid warmer.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OKL | Intravascular Administration Set, Automated Air Removal System | General Hospital | 880.5445 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36437 | Haemodialysis system air/foam detector | A mains electricity (AC-powered) device designed to identify air bubbles and/or foam in blood returned to the body [usually through an arteriovenous fistula (AVF)] by the extracorporeal blood circuit of a haemodialysis system. It may detect the air bubbles/foam using either ultrasonic sensors (i.e., detecting changes in acoustic density), or less frequently using photoelectric sensors (e.g., a photocell). If bubbles/foam are detected, the device usually triggers alarms and activates automated mechanisms to stop the infusion. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00863193000338 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN080009 | 000 |