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| 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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