| Primary Device ID | B842BIOMAX9000 |
| NIH Device Record Key | 27bc1163-e626-40c1-99f3-91b12a2dcfea |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Platinum LED Therapy Lights |
| Version Model Number | BIOMAX900 |
| Catalog Number | BIOMAX900 |
| Company DUNS | 024319954 |
| Company Name | PLATINUM LED HOLDINGS LLC |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Weight | 33 Pound |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Weight | 33 Pound |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Weight | 33 Pound |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Weight | 33 Pound |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Weight | 33 Pound |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Weight | 33 Pound |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Weight | 33 Pound |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Weight | 33 Pound |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Weight | 33 Pound |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Weight | 33 Pound |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Weight | 33 Pound |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Weight | 33 Pound |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Weight | 33 Pound |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Weight | 33 Pound |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Weight | 33 Pound |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Weight | 33 Pound |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Weight | 33 Pound |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Weight | 33 Pound |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Weight | 33 Pound |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Weight | 33 Pound |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Weight | 33 Pound |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Weight | 33 Pound |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Weight | 33 Pound |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Weight | 33 Pound |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Weight | 33 Pound |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B842BIOMAX9000 [Primary] |
| ILY | Lamp, Infrared, Therapeutic Heating |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-06-12 |
| Device Publish Date | 2020-06-04 |
| B842BIOMAX9000 | BIOMAX900 |
| B842BIOMAX6000 | BIOMAX600 |
| B842BIOMAX4500 | BIOMAX450 |
| B842BIOMAX3000 | Biomax 300 |
| B842BIO900RNIR0 | BIO900RNIR |
| B842BIO900R0 | BIO900R |
| B842BIO900NIR0 | BIO900NIR |
| B842BIO600RNIR0 | BIO600RNIR |
| B842BIO600R0 | BIO600R |
| B842BIO600NIR0 | BIO600NIR |
| B842BIO450RNIR0 | BIO450RNIR |
| B842BIO450R0 | BIO450R |
| B842BIO450NIR0 | BIO450NIR |
| B842BIO300RNIR0 | BIO300RNIR |
| B842BIO300R0 | BIO300R |
| B842BIO300NIR0 | BIO300NIR |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PLATINUM LED THERAPY LIGHTS 97115457 not registered Live/Pending |
Platinum LED Lights LLC 2021-11-09 |