| Primary Device ID | 10801741085823 | 
| NIH Device Record Key | 4999c1b9-b7e8-44d8-9e85-fbb0fbf45964 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | GUARDIVA | 
| Version Model Number | FP-24-AD012 | 
| Catalog Number | FP-24-AD012 | 
| Company DUNS | 044611812 | 
| Company Name | Bard Access Systems, Inc. | 
| 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 | 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 | 
| Lumen/Inner Diameter | 7 Millimeter | 
| Outer Diameter | 25 Millimeter | 
| Lumen/Inner Diameter | 7 Millimeter | 
| Outer Diameter | 25 Millimeter | 
| Lumen/Inner Diameter | 7 Millimeter | 
| Outer Diameter | 25 Millimeter | 
| Lumen/Inner Diameter | 7 Millimeter | 
| Outer Diameter | 25 Millimeter | 
| Lumen/Inner Diameter | 7 Millimeter | 
| Outer Diameter | 25 Millimeter | 
| Lumen/Inner Diameter | 7 Millimeter | 
| Outer Diameter | 25 Millimeter | 
| Lumen/Inner Diameter | 7 Millimeter | 
| Outer Diameter | 25 Millimeter | 
| Lumen/Inner Diameter | 7 Millimeter | 
| Outer Diameter | 25 Millimeter | 
| Lumen/Inner Diameter | 7 Millimeter | 
| Outer Diameter | 25 Millimeter | 
| Lumen/Inner Diameter | 7 Millimeter | 
| Outer Diameter | 25 Millimeter | 
| Lumen/Inner Diameter | 7 Millimeter | 
| Outer Diameter | 25 Millimeter | 
| Lumen/Inner Diameter | 7 Millimeter | 
| Outer Diameter | 25 Millimeter | 
| Lumen/Inner Diameter | 7 Millimeter | 
| Outer Diameter | 25 Millimeter | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| 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 | 
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00801741085826 [Primary] | 
| GS1 | 10801741085823 [Package] Contains: 00801741085826 Package: Shelfpack [10 Units] In Commercial Distribution | 
| GS1 | 20801741085820 [Package] Package: Case [10 Units] In Commercial Distribution | 
| FRO | Dressing, wound, drug | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2023-11-17 | 
| Device Publish Date | 2023-11-09 | 
| 10801741085823 | GUARDIVA 1IN/ 7MM STERILE | 
| 20801741085813 | GUARDIVA 1IN/ 4MM STERILE | 
| 10801741085809 | GUARDIVA 1IN/ 1-1/2MM STERILE | 
| 10801741085816 | GUARDIVA 1IN/ 4MM STERILE | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  GUARDIVA  77856523  3915051 Live/Registered | BARD ACCESS SYSTEMS, INC. 2009-10-23 |