DANLEE MEDICAL KIT
- Primary DI
- 00816310020719
- Brand
- DANLEE MEDICAL KIT
- Company
- DANLEE MEDICAL PRODUCTS, INC
- Model
- MOH30240
- Device description
- ECG PREP KIT (ZKIT) VERMED
- Published
- 2016-06-22
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00816310020719 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Electrocardiographic long-term ambulatory recording support kit | A collection of non-sterile, noninvasive devices intended to be used in conjunction with an electrocardiographic (ECG) long-term ambulatory recorder (holter monitor) to facilitate recording. It includes an ECG electrode(s), batteries (to power the recorder), devices intended to assist electrode application (e.g., razor, electrode placement guide, conductive gel, skin cleaning wipe, tape), and may include other patient-supportive devices (e.g., diary/notebook); the recorder is not included. This is a single-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 50 Degrees Fahrenheit | 90 Degrees Fahrenheit | |
Regulatory Flags
- DUNS number
- 878130871
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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