BiliChek B800-50
GUDID 30884838096579
Bilical, 50 Pack
Philips Medical Systems Hsg
Transcutaneous bilirubinometer| Primary Device ID | 30884838096579 |
| NIH Device Record Key | cd05c9a5-279b-4230-bd45-4652bcedf086 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BiliChek |
| Version Model Number | Bilical, 50 Pack |
| Catalog Number | B800-50 |
| Company DUNS | 790605856 |
| Company Name | Philips Medical Systems Hsg |
| Device Count | 50 |
| 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 | false |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884838096578 [Primary] |
| GS1 | 30884838096579 [Unit of Use] |
FDA Product Code
| MQM | Bilirubin (Total And Unbound) In The Neonate Test System |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-31 |
| Device Publish Date | 2022-10-21 |
On-Brand Devices [BiliChek]
| 00884838051751 | Bileclipse, 50 Pack |
| 30884838096579 | Bilical, 50 Pack |
Trademark Results [BiliChek]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BILICHEK 75332565 2512935 Live/Registered |
RIC INVESTMENTS, LLC 1997-07-29 |
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