| Primary Device ID | 10801741223690 |
| NIH Device Record Key | 9d94fa49-65b1-4bdb-a60b-386deff11fea |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AccuCath Ace |
| Version Model Number | PCK00010 |
| Catalog Number | PCK00010 |
| 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 | true |
| Device Combination Product | true |
| 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 |
| Needle Gauge | 20 Gauge |
| Length | 2.25 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2.25 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2.25 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2.25 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2.25 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2.25 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2.25 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2.25 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2.25 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2.25 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2.25 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2.25 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2.25 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2.25 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2.25 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2.25 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2.25 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2.25 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2.25 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2.25 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2.25 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2.25 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2.25 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2.25 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2.25 Inch |
| Needle Gauge | 20 Gauge |
| Length | 2.25 Inch |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00801741223693 [Primary] |
| GS1 | 10801741223690 [Package] Contains: 00801741223693 Package: CA [6 Units] In Commercial Distribution |
| FOZ | Catheter, intravascular, therapeutic, short-term less than 30 days |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-30 |
| Device Publish Date | 2021-07-22 |
| 20801741137956 | AccuCath ACE 20G 2.25”, Basic Kit |
| 20801741137949 | AccuCath ACE 18G 2.25”, Basic Kit |
| 10801741137935 | AccuCath ACE 22G 1.25”, Basic Kit |
| 10801741137928 | AccuCath ACE 20G 1.25”, Basic Kit |
| 10801741137911 | AccuCath ACE 18G 1.25”, Basic Kit |
| 10801741138017 | AccuCath ACE 20G 2.25”, Intermediate Kit |
| 10801741138000 | AccuCath ACE 18G 2.25”, Intermediate Kit |
| 10801741137997 | AccuCath ACE 22G 1.25”, Intermediate Kit |
| 10801741137973 | AccuCath ACE 18G 1.25”, Intermediate Kit |
| 10801741137980 | AccuCath ACE 20G 1.25”, Intermediate Kit |
| 10801741223690 | Catheter Placement Kit |
| 10801741218085 | AccuCath ACE with CUE 20G 2.25”, Intermediate Kit |
| 10801741218078 | AccuCath ACE with CUE 20G 2.25”, Basic Kit |
| 10801741218061 | AccuCath ACE with CUE 18G 2.25”, Intermediate Kit |
| 20801741218051 | AccuCath ACE with CUE 18G 2.25”, Basic Kit |
| 10801741226844 | Catheter Placement Kit |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ACCUCATH ACE 87354572 5746076 Live/Registered |
Vascular Pathways, Inc. 2017-03-01 |