FDA UDI
In Commercial Distribution
🇺🇸 United States
CLEARLINK/CONTINU-FLO/DUO-VENT
DI: 00085412729268
·
Model: UR8519
·
BAXTER HEALTHCARE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- CLEARLINK/CONTINU-FLO/DUO-VENT
- Primary DI
- 00085412729268
- Version / Model
- UR8519
- Catalog Number
- UR8519
- Company Name
- BAXTER HEALTHCARE CORPORATION
- Labeler DUNS
- 005083209
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-24
- Public Version
- 1
- Public Version Date
- 2025-02-03
- Public Version Status
- New
- Public Device Record Key
- 80cecc22-a39e-49e5-aafb-6a5f2a7f93b0
Device Description
Non-DEHP CONTINU-FLO Solution Set with DUO-VENT Spike, 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar, 112" (2.85m) approx., 17.6 mL approx., 10 drops/mL approx.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| FPA | Set, administration, intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58977 | Basic intravenous administration set, noninvasive | A collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50085412729263 | GS1 | CASE | 48 | In Commercial Distribution | |
| Primary | 00085412729268 | GS1 |
Customer Contacts
- Phone
- +1(800)933-0303
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180739 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 112 | Inch |