FDA UDI
In Commercial Distribution
🇺🇸 United States
MediByte Electrode Prep Kit
DI: B1408128201
·
Model: 8128-20
·
Braebon Medical Corporation
Product Codes
2
GMDN Terms
2
Identifiers
2
Pkg Device Count
20
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Basic Information
- Brand Name
- MediByte Electrode Prep Kit
- Primary DI
- B1408128201
- Version / Model
- 8128-20
- Catalog Number
- 8128-20
- Company Name
- Braebon Medical Corporation
- Labeler DUNS
- 251731105
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2019-11-08
- Public Version
- 4
- Public Version Date
- 2024-06-06
- Public Version Status
- Update
- Public Device Record Key
- 1bba935f-3e94-46fc-aa08-dbc30d945ded
Device Description
Consumables to be used with the MediByte. The single-use kit contains: 8597 Oronasal cannula, Snap Electrodes and Alcohol wipes.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| IKD | Cable, Electrode | Physical Medicine | 890.1175 | 2 |
| CAT | Cannula, Nasal, Oxygen | Anesthesiology | 868.5340 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35562 | Electrocardiographic lead set, reusable | A collection of noninvasive devices intended to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device. | No | Active |
| 45566 | Gas-sampling/monitoring respiratory tubing, single-use | A length of flexible noninvasive tube(s) primarily intended to be connected between a tube/mask breathing circuit connector and a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor] for gas pressure or flow monitoring and/or gas sampling; a microbial filter may be included. It is not intended for delivery of medical gas to the patient and does not include a patient mask or nasal cannula. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B1408128201 | HIBCC | ||||
| Unit of Use | B1408128X0 | HIBCC |
Customer Contacts
- Phone
- 888.462.4841
- [email protected]