GUARDIVA FP-23-AD008
GUDID 10801741085816
GUARDIVA 1IN/ 4MM STERILE
Bard Access Systems, Inc.
Percutaneous catheter protector, professional| Primary Device ID | 10801741085816 |
| NIH Device Record Key | 00713860-c2a8-4b94-b5b2-1c6f7a6ac9e8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GUARDIVA |
| Version Model Number | FP-23-AD008 |
| Catalog Number | FP-23-AD008 |
| Company DUNS | 044611812 |
| Company Name | Bard Access Systems, Inc. |
| Device Count | 10 |
| 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 | false |
| Manufacturing Date | false |
| 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
| Lumen/Inner Diameter | 4 Millimeter |
| Outer Diameter | 25 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Outer Diameter | 25 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Outer Diameter | 25 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Outer Diameter | 25 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Outer Diameter | 25 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Outer Diameter | 25 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Outer Diameter | 25 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Outer Diameter | 25 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Outer Diameter | 25 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Outer Diameter | 25 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Outer Diameter | 25 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Outer Diameter | 25 Millimeter |
| Lumen/Inner Diameter | 4 Millimeter |
| Outer Diameter | 25 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00801741085819 [Unit of Use] |
| GS1 | 10801741085816 [Primary] |
| GS1 | 20801741085813 [Package] Package: Case [10 Units] In Commercial Distribution |
FDA Product Code
| FRO | Dressing, wound, drug |
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 | 2025-08-07 |
| Device Publish Date | 2023-11-09 |
On-Brand Devices [GUARDIVA]
| 10801741085823 | GUARDIVA 1IN/ 7MM STERILE |
| 20801741085813 | GUARDIVA 1IN/ 4MM STERILE |
| 10801741085809 | GUARDIVA 1IN/ 1-1/2MM STERILE |
| 10801741085816 | GUARDIVA 1IN/ 4MM STERILE |
Trademark Results [GUARDIVA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GUARDIVA 77856523 3915051 Live/Registered |
BARD ACCESS SYSTEMS, INC. 2009-10-23 |
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