AccessGUDID - DEVICE: ResQCPR System (M5921208250001)

GUDID

Device Identifier (DI) Information

Brand Name: ResQCPR System
Version or Model: 12-0825-000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ADVANCED CIRCULATORY SYSTEMS INC

Primary DI Number: M5921208250001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 140320396 *Terms of Use

Device Description: The ResQCPR system contains two ResQPODs and one ResQPump

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?
41882	Cardiac resuscitator, manual	A manually-operated external device (a hand-powered pump) designed to be applied to the chest of a patient suffering cardiac arrest so that a healthcare professional or layperson can administer rhythmic compression to the chest in the region of the heart to provide blood flow during cardiopulmonary resuscitation (CPR). It typically consists of central piston, a soft but firm base, (a ring) that contacts the chest, a strong spiralled spring that transfers the users applied force to the piston, and a large handle for the user's hands. The compression force can be adjusted to a pre-set load to achieve equal delivered compressions to prevent damage to the ribs/organs. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PIZ	Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

FDA Premarket Submission

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

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: 8f8e8ef6-26d2-4d4d-8065-768da0ce67eb
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: January 19, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
M5921208220000	2	M5921208250001		In Commercial Distribution
M5921208230001	2	M5921208250001		In Commercial Distribution	Bx

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found 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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 651-403-5600
Email: dhowell@zoll.com

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