FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AT-Patch
DI: 08800069700178
·
Model: ATP-C130
·
ATsens Co., Ltd.
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- AT-Patch
- Primary DI
- 08800069700178
- Version / Model
- ATP-C130
- Company Name
- ATsens Co., Ltd.
- Labeler DUNS
- 694967215
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-23
- Public Version
- 3
- Public Version Date
- 2025-11-28
- Public Version Status
- Update
- Public Device Record Key
- 699f9b54-9fb3-4196-bd88-92a89b0a86d7
- Distribution End Date
- 2025-10-31
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
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | Cardiovascular | 870.2800 | 2 |
| DQK | Computer, Diagnostic, Programmable | Cardiovascular | 870.1425 | 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 |
|---|---|---|---|---|---|---|
| Package | 18800069700175 | GS1 | 10 | Not in Commercial Distribution | 2025-10-31 | |
| Primary | 08800069700178 | GS1 | ||||
| Package | 28800069700172 | GS1 | 8 | Not in Commercial Distribution | 2025-10-31 |