Rate Flow®
GUDID 18436020767309
Rate Flow® Regulator IV Set with Universal Spike with 15 micrometer filter, On/Off clamp, Rate Flow Regulator, Injection Site, and Spin-Lock® Connector
LEVENTON SAU
Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive| Primary Device ID | 18436020767309 |
| NIH Device Record Key | 51baad81-b4ab-4b1a-9417-96cf064f059b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rate Flow® |
| Version Model Number | L2590263-V5922 |
| Company DUNS | 461437429 |
| Company Name | LEVENTON SAU |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Length | 83 Inch |
| Length | 83 Inch |
| Length | 83 Inch |
| Length | 83 Inch |
| Length | 83 Inch |
| Length | 83 Inch |
| Length | 83 Inch |
| Length | 83 Inch |
| Length | 83 Inch |
| Length | 83 Inch |
| Length | 83 Inch |
| Length | 83 Inch |
| Length | 83 Inch |
| Length | 83 Inch |
| Length | 83 Inch |
| Length | 83 Inch |
| Length | 83 Inch |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08436020767302 [Primary] |
| GS1 | 18436020767309 [Package] Contains: 08436020767302 Package: Box [50 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K851058
FDA Product Code
| FPA | Set, Administration, Intravascular |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2023-07-17 |
| Device Publish Date | 2016-09-16 |
On-Brand Devices [Rate Flow®]
| 18436020767323 | Rate Flow® Regulator ADDitIV® IV Set with Universal Spike with 15 micrometer filter, Backcheck |
| 18436020767316 | Rate Flow® Regulator ADDitIV® IV Set with Universal Spike with 15 micrometer Filter, On/Off Cl |
| 18436020767309 | Rate Flow® Regulator IV Set with Universal Spike with 15 micrometer filter, On/Off clamp, Rate |
| 18436020767293 | Rate Flow® Regulator IV Set with Universal Spike with 15 micrometer Filter, On/Off Clamp, Rate |
| 18436020767286 | Rate Flow® Regulator IV Set with Universal Spike with 15 micrometer Filter, On/Off Clamp, Rate |
| 18436020767279 | Rate Flow® Regulator IV Set with Universal Spike with 15 micrometer Filter, On/Off Clamp, Rate |
| 18436020767262 | Rate Flow® Regulator IV Set with Universal Spike with 15 micrometer Filter, On/Off Clamp, Rate |
| 18436020767255 | Rate Flow® Regulator IV Set with Universal Spike with 15 micrometer Filter, On/Off Clamp, Rate |
| 08436020767241 | Rate Flow® Regulator Extension Set with Rate Flow Regulator, Injection Site, and Spin-Lock® Co |
| 18436020767231 | Rate Flow® Regulator Extension Set with Rate Flow Regulator, ULTRASITE® Injection Site, and Sp |
| 08436020767227 | Rate Flow® Regulator Extension Set with Rate Flow Regulator, SAFSITE® Injection Site, and Spin |
| 18436020767217 | Rate Flow® Regulator Extension Set with Rate Flow Regulator, SafeLine® Injection Site, and Spi |
Trademark Results [Rate Flow]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RATE FLOW 74392191 1878218 Live/Registered |
B. BRAUN MEDICAL, INC. 1993-05-19 |
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