| Primary Device ID | 00865349000353 |
| NIH Device Record Key | f6e9086d-8378-4744-9b4b-f0b19772fbb4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Firefly IPA Bottle |
| Version Model Number | 40595 |
| Company DUNS | 963236661 |
| Company Name | PURACATH MEDICAL, 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com | |
| Phone | 6505590388 |
| info@puracath.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00865349000353 [Primary] |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-11-21 |
| 00865349000308 - Firefly UV Disinfection Device | 2018-03-29 Battery powered Ultraviolet light disinfection device. |
| 00865349000315 - Firefly Transfer Catheter | 2018-03-29 Perotineal Dialysis Transfer Catheter |
| 00865349000339 - Firefly Luer Cover | 2018-03-29 Luer Cap for the Firefly Transfer Catheter |
| 00865349000353 - Firefly IPA Bottle | 2018-03-2999% IPA bottle for use with the Firefly system |
| 00865349000353 - Firefly IPA Bottle | 2018-03-29 99% IPA bottle for use with the Firefly system |