AccessGUDID - DEVICE: Redicare (B70901020760)

GUDID

Device Identifier (DI) Information

Brand Name: Redicare
Version or Model: Resuscitation Kit
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0102076
Company Name: REDICARE LLC

Primary DI Number: B70901020760
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 800149346 *Terms of Use

Device Description: First Aid Kit to aid in administering Cardiopulmonary Resuscitation (CPR) & reviving a patient who is not breathing. Managed First Aid.

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):	Yes
Kit:	Yes
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?
35693	Cardiopulmonary resuscitation kit, single-use	A collection of items in a portable case intended for cardiopulmonary resuscitation (e.g., airway tubes, face masks, resuscitator). It is typically placed in a convenient location in public buildings and in emergency medical services (EMS) vehicles for quick access in emergency situations. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRR	First Aid Kit With Drug

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: 118522b1-ceed-4b28-9a59-4c65034a0058
Public Version Date: April 03, 2024
Public Version Number: 2
DI Record Publish Date: July 28, 2020