AccessGUDID - DEVICE: PEDIATRIC PADDLE ADAPTER (00883873796146)

GUDID

Device Identifier (DI) Information

Brand Name: PEDIATRIC PADDLE ADAPTER
Version or Model: 11133
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11133-000001
Company Name: PHYSIO-CONTROL, INC.

Primary DI Number: 00883873796146
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009251992 *Terms of Use
Previous DI: 00681490587853

Device Description: ASSY PEDIATRIC PADDLE,ENG, 3RD EDITION

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:	No
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?
44770	External defibrillation electrode, paediatric, reusable	An electrical conductor intended to be used in pairs to transmit a controlled electrical shock from an external defibrillator to a pre-pubescent patient in order to defibrillate the heart (restore a normal rhythm) or slow a rapid heart rate. It usually consists of a cable set that terminates with electrodes (paddles) that are hand-held by the operator to the chest (the intact torso) or back of the patient so that the discharge passes across the region of the heart. Typically available as a set of two electrodes with a combined cable/connector, or as a single electrode with cable/connector, in which case two will be connected to the external pulse generator (EPG). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LDD	Dc-defibrillator, low-energy, (including paddles)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142430	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: f9d39868-8bba-4311-8279-e5a14f8b8aad
Public Version Date: October 28, 2024
Public Version Number: 4
DI Record Publish Date: April 16, 2019