AccessGUDID - DEVICE: P.N.S.™ (10813150020616)

GUDID

Device Identifier (DI) Information

Brand Name: P.N.S.™
Version or Model: A10011
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A10011
Company Name: GRAPHIC CONTROLS ACQUISITION CORP

Primary DI Number: 10813150020616
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 002111896 *Terms of Use

Device Description: Dual Electrode 2/POUCH, 50 POUCHES/BOX, 6 BOXES/CASE, 300 electrodes/case

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
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?
35035	Electrocardiographic electrode, single-use	A non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRX	Electrode, Electrocardiograph

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: b6193395-fa4a-4ccc-8473-ad8a401856c6
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: April 21, 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
30813150020610	6	20813150020613		In Commercial Distribution	CASE
20813150020613	50	10813150020616		In Commercial Distribution	INNER BOX

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 00813150020619 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: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1.800.669.6905
Email: customerservice@vermed.com

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