AccessGUDID - DEVICE: Precision Disposable Products (00865773000318)

GUDID

Device Identifier (DI) Information

Brand Name: Precision Disposable Products
Version or Model: SF08
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: PRECISION DISPOSABLE PRODUCTS INC

Primary DI Number: 00865773000318
Issuing Agency: GS1
Commercial Distribution End Date: January 02, 2019
Device Count: 50
Labeler D-U-N-S® Number*: 080389387 *Terms of Use

Device Description: ECG Electrodes Bag - Circle

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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRX	Electrode, Electrocardiograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K041954	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: 9f6227a4-5194-45d1-b381-8d105b6a431c
Public Version Date: June 23, 2020
Public Version Number: 4
DI Record Publish Date: November 16, 2016