| Primary Device ID | 00884838008540 |
| NIH Device Record Key | 2228642c-5a6a-4263-831a-616a4c869a14 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NIBP Cuffs |
| Version Model Number | NEONATAL SOFT SINGLE-PATIENT CUFF SIZE#3 |
| Catalog Number | M1870S |
| Company DUNS | 314101143 |
| Company Name | Philips Medizin Systeme Böblingen GmbH |
| Device Count | 40 |
| DM Exempt | true |
| 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 | false |
| Lot Batch | true |
| 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 |
| Device Size Text, specify | 0 |
| Circumference | 10.9 Centimeter |
| Device Size Text, specify | 0 |
| Circumference | 10.9 Centimeter |
| Device Size Text, specify | 0 |
| Circumference | 10.9 Centimeter |
| Device Size Text, specify | 0 |
| Circumference | 10.9 Centimeter |
| Device Size Text, specify | 0 |
| Circumference | 10.9 Centimeter |
| Device Size Text, specify | 0 |
| Circumference | 10.9 Centimeter |
| Device Size Text, specify | 0 |
| Circumference | 10.9 Centimeter |
| Device Size Text, specify | 0 |
| Circumference | 10.9 Centimeter |
| Device Size Text, specify | 0 |
| Circumference | 10.9 Centimeter |
| Device Size Text, specify | 0 |
| Circumference | 10.9 Centimeter |
| Device Size Text, specify | 0 |
| Circumference | 10.9 Centimeter |
| Device Size Text, specify | 0 |
| Circumference | 10.9 Centimeter |
| Device Size Text, specify | 0 |
| Circumference | 10.9 Centimeter |
| Device Size Text, specify | 0 |
| Circumference | 10.9 Centimeter |
| Device Size Text, specify | 0 |
| Circumference | 10.9 Centimeter |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884838008540 [Unit of Use] |
| GS1 | 20884838114986 [Primary] |
| DXQ | blood pressure cuff |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-31 |
| Device Publish Date | 2025-03-21 |
| 00884838009042 | Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condit |
| 00884838008588 | Infant Soft Single-Patient Cuff Size #5 |
| 00884838008564 | Neonatal Soft Single-Patient Cuff Size#4 |
| 00884838008540 | Neonatal Soft Single-Patient Cuff Size#3 |
| 00884838008526 | Neonatal Soft Single-Patient Cuff Size#2 |
| 00884838008502 | Neonatal Soft Single-Patient Cuff Size#1 |
| 00884838009127 | Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condit |
| 00884838009103 | Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condit |
| 00884838009080 | Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condit |
| 00884838009066 | Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condit |
| 00884838114920 | Neonatal Soft Single-Patient NIBP Cuffs |
| 00884838114791 | Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condit |
| 00884838114784 | Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condit |
| 00884838114777 | Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condit |
| 00884838114760 | Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condit |
| 00884838114753 | Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condit |
| 00884838114746 | Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condit |
| 00884838114739 | Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condit |
| 00884838114722 | Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condit |
| 00884838114715 | Long-life reusable NIBP cuff/thigh. Premium quality individual cuff w/fluid cap and instructions |
| 00884838114692 | Comfort Care Cuff, Adult Long (navy blue w/edge striping). Limb circumference 27-35cm. Reusable |
| 00884838114678 | Long-life reusable NIBP cuff/small adult Premium quality individual cuff w/fluid cap and instruc |
| 00884838114661 | Long-life reusable NIBP cuff/pediatric. Premium quality individual cuff w/fluid cap and instruct |
| 00884838114654 | Long-life reusable NIBP cuff/infant Premium quality individual cuff w/fluid cap & instructions; |
| 00884838114708 | Long-life reusable NIBP cuff/large adult Premium quality individual cuff w/fluid cap and instruc |
| 00884838114685 | Long-life reusable NIBP cuff/adult. Premium quality individual cuff w/fluid cap and instructions |
| 00884838114869 | Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condit |
| 00884838114807 | Easy Care and Gentle Care Cuffs are not sterile and do not have a defined microbiological condit |