FDA UDI
In Commercial Distribution
🇺🇸 United States
Heart and Respiration Rate Monitoring System powered by EarlySense
DI: 00887761981720
·
Model: P211560
·
HILL-ROM, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Heart and Respiration Rate Monitoring System powered by EarlySense
- Primary DI
- 00887761981720
- Version / Model
- P211560
- Company Name
- HILL-ROM, INC.
- Labeler DUNS
- 004245668
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-23
- Public Version
- 1
- Public Version Date
- 2021-10-01
- Public Version Status
- New
- Public Device Record Key
- f2426991-43c3-4efe-a1d8-8d2bb23b88a7
Device Description
EarlySense Sensor Assembly
Device Characteristics
- Single Use
- No
- 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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| BZQ | Monitor, breathing frequency | Anesthesiology | 868.2375 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36553 | Patient monitoring system module, multifunction | A small unit dedicated to the measurement and displays of several physiological parameters, e.g., electrical activity of the heart, respiratory rate, temperature, blood pressure, pulse, and oximetry. The signals are obtained through connected cables/leads/probes. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which then operates as a mainframe computer displaying the various parameters/information measured and provided by this module. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00887761975705 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 00887761981720 | GS1 | ||||
| Package | 00887761975712 | GS1 | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)445-3730
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180079 | 000 |