FDA UDI
In Commercial Distribution
🇺🇸 United States
NeoHeart®
DI: 10812594012737
·
Model: Small
·
Neotech Products LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- NeoHeart®
- Primary DI
- 10812594012737
- Version / Model
- Small
- Catalog Number
- N335
- Company Name
- Neotech Products LLC
- Labeler DUNS
- 198013435
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2018-07-16
- Public Version
- 5
- Public Version Date
- 2023-09-20
- Public Version Status
- Update
- Public Device Record Key
- 4580d48b-c151-4842-83b7-ff7b1721b8db
Device Description
NeoHeart is a set of three attached ECG electrodes used on term neonates, infants, and pediatric patients. An electrocardiograph electrode (per FDA regulation# 870.2360 ) is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.
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
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DRX | Electrode, Electrocardiograph | Cardiovascular | 870.2360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17460 | Neonatal electrocardiographic electrode | A non-sterile electrical conductor applied to a neonatal patient to transmit electrical signals from the body surface to a data measuring/display device (typicaly an electrocardiograph, patient monitor, or patient monitoring system) to produce 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 |
|---|---|---|---|---|---|---|
| Primary | 10812594012737 | GS1 | ||||
| Unit of Use | 00812594012730 | GS1 |