| Primary Device ID | 10860003561925 |
| NIH Device Record Key | c6e376dd-8ccc-4eab-92a4-0634a9fef368 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Safe PICO Kit |
| Version Model Number | 623-KIT Box of 100 |
| Company DUNS | 086661485 |
| Company Name | RADIOMETER AMERICA 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 8007360600 |
| support@radiometeramerica.com | |
| Phone | 8007360600 |
| support@radiometeramerica.com | |
| Phone | 8007360600 |
| support@radiometeramerica.com | |
| Phone | 8007360600 |
| support@radiometeramerica.com | |
| Phone | 8007360600 |
| support@radiometeramerica.com | |
| Phone | 8007360600 |
| support@radiometeramerica.com | |
| Phone | 8007360600 |
| support@radiometeramerica.com | |
| Phone | 8007360600 |
| support@radiometeramerica.com | |
| Phone | 8007360600 |
| support@radiometeramerica.com | |
| Phone | 8007360600 |
| support@radiometeramerica.com | |
| Phone | 8007360600 |
| support@radiometeramerica.com | |
| Phone | 8007360600 |
| support@radiometeramerica.com | |
| Phone | 8007360600 |
| support@radiometeramerica.com | |
| Phone | 8007360600 |
| support@radiometeramerica.com | |
| Phone | 8007360600 |
| support@radiometeramerica.com | |
| Phone | 8007360600 |
| support@radiometeramerica.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 32 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10860003561925 [Primary] |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-25 |
| Device Publish Date | 2021-02-17 |
| 00860003561904 | 1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Sterile Gauze Pad, 1-Bio Bag with gusset bottom, 1 saf |
| 10860003561925 | 1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Sterile Gauze Pad, 1-Bio Bag with gusset bottom, 1 saf |
| 10860003561901 | 1-Adhesive Bandage, 1-Alcohol Prep Pad, 1-Sterile Gauze Pad, 1-Bio Bag with gusset bottom, 1 saf |