FDA UDI
In Commercial Distribution
🇺🇸 United States
Gateway
DI: M581NEMK1560
·
Model: Gateway
·
Northeast Monitoring, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Gateway
- Primary DI
- M581NEMK1560
- Version / Model
- Gateway
- Catalog Number
- NEMK156
- Company Name
- Northeast Monitoring, Inc.
- Labeler DUNS
- 837441815
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-27
- Public Version
- 1
- Public Version Date
- 2021-11-04
- Public Version Status
- New
- Public Device Record Key
- dc4d23cf-d90a-44dd-b939-5d5d2de09790
Device Description
Gateway NEMK156
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 |
|---|---|---|---|---|
| 36827 | Electrocardiographic long-term ambulatory recording analyser | An electronic device intended to be used for the analysis of long-term (often 24-hours) heart activity data, which has previously been registered by an electrocardiographic long-term ambulatory recorder (Holter), to which the patient was connected and carried upon his or her person. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M581NEMK1560 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142424 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 3.8 | Centimeter | |
| Length | 6.7 | Centimeter | |
| Depth | 1.2 | Centimeter | |
| Weight | 35 | Gram |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Allowed Storage Conditions: -20C to 60C up to 1 month, and -20C to 30C for long term