| Primary Device ID | 04046964336836 |
| NIH Device Record Key | 0a6cc7c8-ffb3-419a-973c-949f45879307 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Z-MED II™ |
| Version Model Number | 611723 |
| Catalog Number | 611723 |
| Company DUNS | 784259751 |
| Company Name | B BRAUN INTERVENTIONAL 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 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Special Storage Condition, Specify | Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04046964336836 [Primary] |
| OZT | Balloon aortic valvuloplasty |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-03-25 |
| Device Publish Date | 2016-08-09 |
| 04046964338342 | SO045 SPECIAL ZMED II 25X3X120 |
| 04046964338328 | SO044 SPECIAL ZMED II 23X3X120 |
| 04046964338281 | SO042 SPECIAL ZMED II 25X2X85 |
| 04046964338243 | SO040 SPECIAL ZMED II 25X2X100 |
| 04046964338229 | SO039 SPECIAL ZMED II 11X4X100 |
| 04046964338007 | SO028 SPECIAL ZMED II 11X3X100 |
| 04046964337772 | PDZ671 SPECIAL ZMED II 25X6X100 |
| 04046964337758 | PDZ670 ZMED II 25X5X100 |
| 04046964337734 | PDZ669 ZMED II 25X4X100 |
| 04046964337710 | PDZ668 SPECIAL ZMED II 25X3X100 |
| 04046964337697 | PDZ667 SPECIAL ZMED II 23X6X100 |
| 04046964337673 | PDZ666 SPECIAL ZMED II 23X5X100 |
| 04046964337659 | PDZ665 ZMED II 23X4X100 |
| 04046964337635 | PDZ664 SPECIAL ZMED II 23X3X100 |
| 04046964337611 | PDZ663 SPECIAL ZMED II 22X6X100 |
| 04046964337598 | PDZ662 SPECIAL ZMED II 22X5X100 |
| 04046964337574 | PDZ661 ZMED II 22X4X100 |
| 04046964337543 | PDZ659 SPECIAL ZMED II 20X6X100 |
| 04046964337529 | PDZ658 SPECIAL ZMED II 20X5X100 |
| 04046964337499 | PDZ657 ZMED II 20X4X100 |
| 04046964337475 | PDZ656 SPECIAL ZMED II 20X3X100 |
| 04046964337451 | PDZ655 ZMED II 18X6X100 |
| 04046964337437 | PDZ654 SPECIAL ZMED II 18X5X100 |
| 04046964337413 | PDZ653 ZMED II 18X4X100 |
| 04046964337390 | PDZ652 ZMED II 18X3X100 |
| 04046964337376 | PDZ651 ZMED II 16X6X100 |
| 04046964337352 | PDZ650 SPECIAL ZMED II 16X5X100 |
| 04046964337338 | PDZ649 ZMED II 16X4X100 |
| 04046964337314 | PDZ648 ZMED II 16X3X100 |
| 04046964337291 | PDZ647 SPECIAL ZMED II 15X6X100 |
| 04046964337277 | PDZ646 SPECIAL ZMED II 15X5X100 |
| 04046964337253 | PDZ645 ZMED II 15X4X100 |
| 04046964337239 | PDZ644 ZMED II 15X3X100 |
| 04046964337215 | PDZ643 SPECIAL ZMED II 14X6X100 |
| 04046964337192 | PDZ642 SPECIAL ZMED II 14X5X100 |
| 04046964337178 | PDZ641 ZMED II 14X4X100 |
| 04046964337154 | PDZ640 ZMED II 14X3X100 |
| 04046964337130 | PDZ639 SPECIAL ZMED II 12X6X100 |
| 04046964337116 | PDZ638 SPECIAL ZMED II 12X5X100 |
| 04046964337093 | PDZ637 ZMED II 12X4X100 |
| 04046964337079 | PDZ636 ZMED II 12X3X100 |
| 04046964337062 | PDZ635 ZMED II 12X2X100 |
| 04046964337048 | PDZ634 SPECIAL ZMED II 10X6X100 |
| 04046964337024 | PDZ633 SPECIAL ZMED II 10X5X100 |
| 04046964337000 | PDZ632 ZMED II 10X4X100 |
| 04046964336997 | PDZ631 ZMED II 10X3X100 |
| 04046964336966 | PDZ630 ZMED II 10X2X100 |
| 04046964336942 | PDZ629 SPECIAL ZMED II 9X6X100 |
| 04046964336928 | PDZ628 SPECIAL ZMED II 9X5X100 |
| 04046964336911 | PDZ627 SPECIAL ZMED II 9X4X100 |