FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Precision Disposable Products
DI: 00865773000332
·
Model: SF22
·
PRECISION DISPOSABLE PRODUCTS INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2000
Basic Information
- Brand Name
- Precision Disposable Products
- Primary DI
- 00865773000332
- Version / Model
- SF22
- Company Name
- PRECISION DISPOSABLE PRODUCTS INC
- Labeler DUNS
- 080389387
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 2000
- Record Status
- Published
- Publish Date
- 2016-11-16
- Public Version
- 4
- Public Version Date
- 2020-06-23
- Public Version Status
- Update
- Public Device Record Key
- e60e4289-5728-4a1b-bcfa-a3fa5716ee74
- Distribution End Date
- 2019-01-02
Device Description
ECG Electrodes Case - Square
Device Characteristics
- Single Use
- Yes
- 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
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DRX | Electrode, Electrocardiograph | Cardiovascular | 870.2360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37694 | Nitrogen terminal unit | A device that is a component of a medical gas pipeline system or a medical gas/vacuum pipeline system that has a gas-specific outlet connection for nitrogen (N2). It is designed to be mounted to wall-mounted medical supply units, utility supply systems (ceiling pendants), or directly to a wall, and functions as the outlet assembly of a gas pipeline system to which the operator can connect/disconnect a device, e.g., a surgical power tool or a laboratory device. It may incorporate a dual connection where one serves as a return for removal of the exhaust nitrogen. On disconnection of the device from the outlet, it will self seal the gas pipeline system preventing gas leakage to the environment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00865773000332 | GS1 | ||||
| Unit of Use | 00865773000356 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K041954 | 000 |