| Primary Device ID | 20816789010239 |
| NIH Device Record Key | cd2c453a-87b4-4b62-9034-d54f7ecdebfc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UltraMIST Applicator |
| Version Model Number | CP-80034 |
| Catalog Number | CP-80034 |
| Company DUNS | 872967679 |
| Company Name | ALLIQUA BIOMEDICAL, 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 844-963-2273 |
| MIST.CS@alliqua.com | |
| Phone | 844-963-2273 |
| MIST.CS@alliqua.com | |
| Phone | 844-963-2273 |
| MIST.CS@alliqua.com |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816789010235 [Primary] |
| GS1 | 10816789010232 [Package] Contains: 00816789010235 Package: Dispenser pack [6 Units] In Commercial Distribution |
| GS1 | 20816789010239 [Package] Contains: 10816789010232 Package: Corrugated carton [1 Units] In Commercial Distribution |
| GS1 | 30816789010236 [Package] Contains: 00816789010235 Package: Dispenser pack [12 Units] In Commercial Distribution |
| GS1 | 40816789010233 [Package] Contains: 30816789010236 Package: Corrugated Carton [1 Units] In Commercial Distribution |
| NRB | Wound Cleaner, Ultrasound |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20816789010239]
Radiation Sterilization
[20816789010239]
Radiation Sterilization
[20816789010239]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-07 |
| 10816789010201 - UltraMIST Treatment Wand | 2018-07-06 A hand-held mains electricity electronic component of a wound therapy ultrasound system intended to convert (transduce) electric |
| 00816789010211 - UltraMIST Generator | 2018-07-06 A portable assembly of mains electricity devices intended to deliver low frequency ultrasound energy via a fluid mist to a wound |
| 20816789010239 - UltraMIST Applicator | 2018-07-06A sterile component of a wound therapy ultrasound system intended to be attached to the system treatment wand to interface low frequency ultrasound energy from the treatment wand with a fluid solution (e.g., saline) for the production of an ultrasound-conductive mist used to promote wound healing. It typically includes fluid delivery tubing and is intended to fit on the distal end of the treatment wand. This is a single-use device. |
| 20816789010239 - UltraMIST Applicator | 2018-07-06 A sterile component of a wound therapy ultrasound system intended to be attached to the system treatment wand to interface low f |
| 20816789010246 - MIST 360 Applicator | 2018-07-06 A sterile component of a wound therapy ultrasound system intended to be attached to the system treatment wand to interface low f |
| 20816789010253 - MIST Therapy Applicator | 2018-07-06 A sterile component of a wound therapy ultrasound system intended to be attached to the system treatment wand to interface low f |