| Primary Device ID | 20801741152447 |
| NIH Device Record Key | b61fa748-cdfc-4a94-b55c-de5d216a84b0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PowerGlide Pro |
| Version Model Number | F118080TX |
| Catalog Number | F118080TX |
| Company DUNS | 044611812 |
| Company Name | Bard Access Systems, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com | |
| Phone | +1(800)545-0890 |
| medical.services@crbard.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Length | 8 Centimeter |
| Device Size Text, specify | 0 |
| Length | 8 Centimeter |
| Device Size Text, specify | 0 |
| Length | 8 Centimeter |
| Device Size Text, specify | 0 |
| Length | 8 Centimeter |
| Device Size Text, specify | 0 |
| Length | 8 Centimeter |
| Device Size Text, specify | 0 |
| Length | 8 Centimeter |
| Device Size Text, specify | 0 |
| Length | 8 Centimeter |
| Device Size Text, specify | 0 |
| Length | 8 Centimeter |
| Device Size Text, specify | 0 |
| Length | 8 Centimeter |
| Device Size Text, specify | 0 |
| Length | 8 Centimeter |
| Device Size Text, specify | 0 |
| Length | 8 Centimeter |
| Device Size Text, specify | 0 |
| Length | 8 Centimeter |
| Device Size Text, specify | 0 |
| Length | 8 Centimeter |
| Device Size Text, specify | 0 |
| Length | 8 Centimeter |
| Device Size Text, specify | 0 |
| Length | 8 Centimeter |
| Device Size Text, specify | 0 |
| Length | 8 Centimeter |
| Device Size Text, specify | 0 |
| Length | 8 Centimeter |
| Device Size Text, specify | 0 |
| 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 | 00801741152443 [Primary] |
| GS1 | 10801741152440 [Package] Contains: 00801741152443 Package: CA [5 Units] In Commercial Distribution |
| GS1 | 20801741152447 [Package] Contains: 10801741152440 Package: BX [2 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 | 2018-11-30 |
| Device Publish Date | 2018-10-30 |
| 10801741152921 | DOT PG Pro 22G 8cm RT Max W/NG |
| 10801741152914 | DOT PG Pro 20G 10cm RT Max W/NG |
| 10801741152907 | DOT PG Pro 20G 8cm RT Max W/NG |
| 10801741152891 | DOT PG Pro 18G 10cm RT Max W/NG |
| 10801741152884 | DOT PG Pro 18G 8cm RT Max W/NG |
| 10801741152877 | PG Pro 22G 8cm RT Full W/NG |
| 10801741152860 | PG Pro 20G 10cm RT Full W/NG |
| 10801741152853 | PG Pro 20G 8cm RT Full W/NG |
| 10801741152846 | PG Pro 18G 10cm RT Full W/NG |
| 10801741152839 | PG Pro 18G 8cm RT Full W/NG |
| 10801741152822 | PG Pro 22G 8cm RT Full w/GIva&NG |
| 10801741152815 | PG Pro 20G 10cm RT Full w/GIva&NG |
| 10801741152808 | PG Pro 20G 8cm RT Full w/GIva&NG |
| 10801741152792 | PG Pro 18G 10cm RT Full w/GIva&NG |
| 10801741152785 | PG Pro 18G 8cm RT Full w/GIva&NG |
| 10801741152778 | DOT PG Pro 22G 8cm RT Full B&P w/NG |
| 10801741152761 | DOT PG Pro 20G10cm RT Full B&P w/NG |
| 10801741152754 | DOT PG Pro 20G 8cm RT Full B&P w/NG |
| 10801741152747 | DOT PG Pro 18G10cm RT Full B&P w/NG |
| 10801741152730 | DOT PG Pro 18G 8cm RT Full B&P w/NG |
| 10801741152723 | DOT PG Pro 22G 8cm RT Full PCover w/NG |
| 10801741152709 | DOT PG Pro 20G10cm RT Full PCover w/NG |
| 10801741152693 | DOT PG Pro 20G 8cm RT Full PCover w/NG |
| 10801741152686 | DOT PG Pro 18G10cm RT Full PCover w/NG |
| 10801741152679 | DOT PG Pro 18G 8cm RT Full PCover w/NG |
| 10801741152662 | DOT PG Pro 22G 8cm RT Full G&P w/NG |
| 10801741152655 | DOT PG Pro 20G10cm RT Full G&P w/NG |
| 10801741152648 | DOT PG Pro 20G 8cm RT Full G&P w/NG |
| 10801741152556 | DOT PG Pro 18G10cm RT Full G&P w/NG |
| 10801741152549 | DOT PG Pro 18G 8cm RT Full G&P w/NG |
| 10801741152532 | DOT PG Pro 22G 8cm RT Full BioPatch w/NG |
| 10801741152525 | DOT PG Pro 20G10cm RT Full BioPatch w/NG |
| 10801741152518 | DOT PG Pro 20G 8cm RT Full BioPatch w/NG |
| 10801741152501 | DOT PG Pro 18G10cm RT Full BioPatch w/NG |
| 10801741152495 | DOT PG Pro 18G 8cm RT Full BioPatch w/NG |
| 10801741152488 | PG Pro 22G 8cm RT Basic W/NG |
| 20801741152478 | PG Pro 20G 10cm RT Basic W/NG |
| 20801741152461 | PG Pro 20G 8cm RT Basic W/NG |
| 20801741152454 | PG Pro 18G 10cm RT Basic W/NG |
| 20801741152447 | PG Pro 18G 8cm RT Basic W/NG |
| 20801741152430 | PG Pro 22G 8cm RT Basic w/GIva&NG |
| 20801741152423 | PG Pro 20G10cm RT Basic w/GIva&NG |
| 10801741152419 | PG Pro 20G 8cm RT Basic w/GIva&NG |
| 20801741152409 | PG Pro 18G10cm RT Basic w/GIva&NG |
| 20801741152393 | PG Pro 18G 8cm RT Basic w/GIva&NG |
| 10801741152389 | PG Pro 22G 8cm RT Basic BioPatch w/NG |
| 10801741152372 | PG Pro 20G10cm RT Basic BioPatch w/NG |
| 20801741152362 | PG Pro 20G 8cm RT Basic BioPatch w/NG |
| 10801741152358 | PG Pro 18G10cm RT Basic BioPatch w/NG |
| 10801741152341 | PG Pro 18G 8cm RT Basic BioPatch w/NG |