FDA UDI
In Commercial Distribution
🇺🇸 United States
Eclipse Mini
DI: 10841522129209
·
Model: Eclipse Mini
·
SPACELABS HEALTHCARE (WASHINGTON), INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Eclipse Mini
- Primary DI
- 10841522129209
- Version / Model
- Eclipse Mini
- Catalog Number
- 98900-L
- Company Name
- SPACELABS HEALTHCARE (WASHINGTON), INC
- Labeler DUNS
- 145581588
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-19
- Public Version
- 1
- Public Version Date
- 2024-03-27
- Public Version Status
- New
- Public Device Record Key
- ecea8baa-b173-4cf7-9026-432ea5030d39
Device Description
ECLIPSE MINI RECORDER, MULTILINGUAL,LOAN
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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| MWJ | Electrocardiograph, ambulatory (without analysis) | Cardiovascular | 870.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35162 | Electrocardiographic ambulatory recorder | An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10841522129209 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212317 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 70 Degrees Celsius