Premicath 1261.306G
GUDID 38498840008523
PREMICATH 28 G (1 FR) 30 CM CATHETER WITH STYLET
Vygon Corporation
Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter| Primary Device ID | 38498840008523 |
| NIH Device Record Key | 45f50a89-dba0-4976-b7b2-4bd7f19e176b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Premicath |
| Version Model Number | 1261.306G |
| Catalog Number | 1261.306G |
| Company DUNS | 120818216 |
| Company Name | Vygon Corporation |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Device Dimensions
| Outer Diameter | 24 Millimeter |
| Outer Diameter | 24 Millimeter |
| Outer Diameter | 24 Millimeter |
| Outer Diameter | 24 Millimeter |
| Outer Diameter | 24 Millimeter |
| Outer Diameter | 24 Millimeter |
| Outer Diameter | 24 Millimeter |
| Outer Diameter | 24 Millimeter |
| Outer Diameter | 24 Millimeter |
| Outer Diameter | 24 Millimeter |
| Outer Diameter | 24 Millimeter |
| Outer Diameter | 24 Millimeter |
| Outer Diameter | 24 Millimeter |
| Outer Diameter | 24 Millimeter |
| Outer Diameter | 24 Millimeter |
| Outer Diameter | 24 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08498840008522 [Primary] |
| GS1 | 38498840008523 [Package] Contains: 08498840008522 Package: [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K041468
FDA Product Code
| LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-02-19 |
| Device Publish Date | 2015-10-08 |
On-Brand Devices [Premicath]
| 30849884002356 | PREMICATH 28 G (1 FR) 30 CM CATHETER WITH STYLET |
| 30849884002325 | PREMICATH 28 G (1 FR) 20 CM CATHETER AND SPLITTING NEEDLE |
| 30849884002318 | PREMICATH 28 G (1 FR) 20 CM CATHETER WITH STYLET AND MICROFLASH INTRODUCER |
| 30849884002301 | PREMICATH 28 G (1 FR) 20 CM CATHETER WITH STYLET AND 24 G CANNULA |
| 30849884002295 | PREMICATH 28 G (1 FR) 20 CM CATHETER WITH STYLET AND NEOCATH SPLIT |
| 30849884001168 | PREMICATH 28 G (1 FR) 20 CM CATHETER WITH STYLET AND SPLITTING NEEDLE |
| 38498840009537 | PREMICATH 28 G (1 FR) 20 CM CATHETER WITH STYLET AND NEOCATH SPLIT |
| 38498840008523 | PREMICATH 28 G (1 FR) 30 CM CATHETER WITH STYLET |
| 38498840008516 | PREMICATH 28 G (1 FR) 20 CM CATHETER AND SPLITTING NEEDLE |
| 38498840008509 | PREMICATH 28 G (1 FR) 20 CM CATHETER WITH STYLET AND MICROFLASH INTRODUCER |
| 38498840008493 | PREMICATH 28 G (1 FR) 20 CM CATHETER WITH STYLET AND 24 G CANNULA |
| 38498840008486 | PREMICATH 28 G (1 FR) 20 CM CATHETER WITH STYLET AND SPLITTING NEEDLE |
| 38498840008479 | PREMICATH 28 G (1 FR) 15 CM CATHETER WITH STYLET AND 24 G CANNULA |
Trademark Results [Premicath]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PREMICATH 78904190 3206321 Live/Registered |
Vygon 2006-06-08 |
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