AccessGUDID - DEVICE: AutoPulse Multi-Chemistry Battery Charger (00849111002028)

GUDID

Device Identifier (DI) Information

Brand Name: AutoPulse Multi-Chemistry Battery Charger
Version or Model: 100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8700-0753-15
Company Name: Zoll Circulation, Inc.

Primary DI Number: 00849111002028
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 799455241 *Terms of Use

Device Description: Charges and automatically conditions two NiMH or Li-Ion batteries and automatically verifies battery charge level.

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?
17115	Noninvasive device battery charger	An electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRM	Compressor, Cardiac, External

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112998	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
Storage Environment Temperature: between -40 and 158 Degrees Fahrenheit
Handling Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 41 and 95 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 23ebec0e-b13b-4cc3-8321-e463c8c18b9a
Public Version Date: February 06, 2020
Public Version Number: 4
DI Record Publish Date: July 24, 2015