FDA UDI
In Commercial Distribution
🇺🇸 United States
NeoBeat Mini Sys Newborn Heart Rate Meter
DI: 07045432118339
·
Model: 531-00001
·
Laerdal Medical AS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NeoBeat Mini Sys Newborn Heart Rate Meter
- Primary DI
- 07045432118339
- Version / Model
- 531-00001
- Catalog Number
- 531-00001
- Company Name
- Laerdal Medical AS
- Labeler DUNS
- 730624095
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-13
- Public Version
- 1
- Public Version Date
- 2024-12-23
- Public Version Status
- New
- Public Device Record Key
- da5104f6-f969-4c86-aa7f-8e3c16310c47
Device Description
NeoBeat is a heart rate measurement device using dry-electrode technology, with integrated digital display.
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 |
|---|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Cardiovascular | 870.2300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63619 | Wearable neonatal heart rate meter | An electrically-powered device designed to detect and display the heart rate of a neonate, typically within the first few hours after delivery. It consists of a display screen with sensor arms on each side, which are placed around the torso of the newborn. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07045432118339 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232111 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Short-term storage temperature: -20 - 60 °C
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 62 – 106 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity