FDA UDI
In Commercial Distribution
🇺🇸 United States
ZAP GUARD
DI: B22391766
·
Model: MONO
·
GUARDIAN ANGEL PRODUCTS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ZAP GUARD
- Primary DI
- B22391766
- Version / Model
- MONO
- Company Name
- GUARDIAN ANGEL PRODUCTS INC
- Labeler DUNS
- 610797672
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-14
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- f831b0c6-7881-4c1d-83a5-959c68de614e
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
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DRL | Tester, Defibrillator | Cardiovascular | 870.5325 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13340 | Line cord resistance tester | An instrument designed to measure resistance to the direct current (DC) of a circuit conductor. It may consist of a simple unit that detects continuity and shows the results using lighted displays [(e.g., light-emitting diodes (LEDs)], or use a four-terminal technique to measure resistance (e.g., in milliohms) and display the numeric results; it typically includes a DC power supply (e.g., a battery). The device may include visual or audible signals that are activated when the circuit is open and/or the resistance is under a predetermined value. It is used to determine the continuity of conductors and other low resistances such as the contact resistance in electrical receptacles. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B22391766 | HIBCC |