FDA UDI
In Commercial Distribution
🇺🇸 United States
SA-3000P
DI: 00191237000014
·
Model: SA-3000P
·
Medicore Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- SA-3000P
- Primary DI
- 00191237000014
- Version / Model
- SA-3000P
- Catalog Number
- SA-3000P
- Company Name
- Medicore Co., Ltd.
- Labeler DUNS
- 688247753
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-10
- Public Version
- 1
- Public Version Date
- 2019-04-18
- Public Version Status
- New
- Public Device Record Key
- 3be4ad50-16ea-48c1-a9da-e9d0fb126b11
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | Cardiovascular | 870.2780 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13671 | Sphygmograph | A device that functions as a graphic printer of the waveform of the arterial pulse. This instrument usually includes a lever, the short end of which rests on the radial artery at the wrist, its long end being provided with a stylet which records (usually on a moving paper) the excursions of the pulse. The waveform typically consists of a curve having a sudden rise, followed by a sudden fall, after which there is a gradual descend marked by a number of secondary elevations. This GMDN code may reflect old technology. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10191237000011 | GS1 | Carton | 1 | In Commercial Distribution | |
| Primary | 00191237000014 | GS1 |
Customer Contacts
- Phone
- +82220562650
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K073323 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 80 Percent (%) Relative Humidity