AccessGUDID - DEVICE: HUDSON RCI (14026704662583)

GUDID

Device Identifier (DI) Information

Brand Name: HUDSON RCI
Version or Model: IPN039380
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1178
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 14026704662583
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 04026704582228

Device Description: Lifesaver CPR Board

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?
34906	Cardiac compression board	A flat, rigid device intended to be placed under a patient to provide the necessary support required for the application of cardiopulmonary resuscitation (CPR), either manually applied or using a powered cardiac resuscitator. It may be suitable for placing on a bed or other soft surface and/or may have fixings for the attachment of straps used to secure a powered cardiac resuscitator. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FOA	BOARD, CARDIOPULMONARY

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: e22518fc-cf65-44a1-a9f8-7b4fda4c4f37
Public Version Date: January 11, 2024
Public Version Number: 5
DI Record Publish Date: August 07, 2019