FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Ambu WhiteSensor 4535M
DI: 05707480141609
·
Model: 4535M/3
·
Ambu A/S
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
3
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Basic Information
- Brand Name
- Ambu WhiteSensor 4535M
- Primary DI
- 05707480141609
- Version / Model
- 4535M/3
- Catalog Number
- 4535M/3
- Company Name
- Ambu A/S
- Labeler DUNS
- 305682023
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2019-06-03
- Public Version
- 3
- Public Version Date
- 2026-01-30
- Public Version Status
- Update
- Public Device Record Key
- aaa6c8bb-c47e-42b8-9036-d01a9fa2581d
- Distribution End Date
- 2020-09-10
Device Description
Ambu WhiteSensor ST Monitoring Wet Gel
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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 35035 | Electrocardiographic electrode, single-use | A non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05707480141616 | GS1 | 200 | Not in Commercial Distribution | 2020-09-10 | |
| Primary | 05707480141609 | GS1 | ||||
| Package | 05707480141623 | GS1 | 6 | Not in Commercial Distribution | 2020-09-10 | |
| Unit of Use | 05707480141593 | GS1 |
Customer Contacts
- Phone
- +1(410)768-6464
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius