AccessGUDID - DEVICE: ZAP GUARD (B22391766)

GUDID

Device Identifier (DI) Information

Brand Name: ZAP GUARD
Version or Model: MONO
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GUARDIAN ANGEL PRODUCTS INC

Primary DI Number: B22391766
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 610797672 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRL	Tester, Defibrillator

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f831b0c6-7881-4c1d-83a5-959c68de614e
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: March 14, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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