FDA UDI
In Commercial Distribution
🇺🇸 United States
Fetal Monitoring Recording Paper
DI: 30884838011794
·
Model: Fetal Monitoring Recording Paper
·
Philips Medizin Systeme Böblingen GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
40
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Fetal Monitoring Recording Paper
- Primary DI
- 30884838011794
- Version / Model
- Fetal Monitoring Recording Paper
- Catalog Number
- 989803157181
- Company Name
- Philips Medizin Systeme Böblingen GmbH
- Labeler DUNS
- 314101143
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 40
- Record Status
- Published
- Publish Date
- 2026-03-27
- Public Version
- 1
- Public Version Date
- 2026-04-06
- Public Version Status
- New
- Public Device Record Key
- 8c3e977a-e35f-47ca-8b69-cfbbeafaf75e
Device Description
Fetal Monitoring Recording Paper
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DSF | Recorder, Paper Chart | Cardiovascular | 870.2810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16754 | Electrocardiographic recording paper | A device prepared from a thin sheet of fibrous material, typically with preprinted graphics and designed for recording the output of an electrocardiograph (ECG), or other device, in the form of measured physiologic parameters as an electrocardiogram (ECG). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00884838011793 | GS1 | ||||
| Primary | 30884838011794 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 104 Degrees Fahrenheit
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 16 – 107.5 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 70 Percent (%) Relative Humidity