| Primary Device ID | 00304040001387 |
| NIH Device Record Key | b48bb5e8-4419-4f9d-aadd-4a3df1121019 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Henry Schein OneStep |
| Version Model Number | 1125547 |
| Catalog Number | 1125547 |
| Company DUNS | 012430880 |
| Company Name | HENRY SCHEIN, 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 | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00304040001387 [Primary] |
| KTN | SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-11-08 |
| Device Publish Date | 2016-09-24 |
| 00304040193198 - Henry Schein | 2025-09-22 Adult SpO2 Pulse Oximeter Sensor |
| 00304040193266 - Henry Schein | 2025-09-22 Vital Signs Monitor Cuff Extra Large |
| 00304040193228 - Henry Schein | 2025-09-17 Vital Signs Monitor Infrared Forehead Thermometer |
| 00304040193242 - Henry Schein | 2025-09-17 Pediatric SpO2 Pulse Oximeter Sensor |
| 00304040193181 - Henry Schein | 2025-09-17 Dr. Harrison Vein Pack |
| 00304040193150 - Henry Schein | 2025-09-11 Stretcher Sheet |
| 00304040193167 - Henry Schein | 2025-09-11 Aff Perio of NJ Surg Pack |
| 00304040193099 - Henry Schein | 2025-09-03 Pack Shoulder Arthroscopy F/ M Kit |