AccessGUDID - DEVICE: AMCO (00853258006061)

GUDID

Device Identifier (DI) Information

Brand Name: AMCO
Version or Model: 5L318
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5L318
Company Name: Amco International Manufacturing & Design, Inc.

Primary DI Number: 00853258006061
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 830424854 *Terms of Use

Device Description: Lithium replacement battery for Philips(TM) Heartstream ForeRunner(TM) AED (BT1)

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):	No
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?
38558	Primary battery	A non-rechargeable set of electrochemical cells, or a single cell, designed to store chemical energy and release it in the form of electrical energy to provide power for active implantable medical devices or external medical instruments, for backup power for programmable devices that must retain electronic information, or to power portable or other medical devices when it is not possible or convenient to use the line supply. The device includes terminals and may include a case. The size, shape, and chemical composition of the device should be specified according to the requirements in "IEC 60086-1 Primary batteries - Part 1: General", or the latest version of this standard.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MKJ	Automated External Defibrillators (Non-Wearable)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091548	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: 65400a5a-1c5c-45a2-9e91-b68353681e0e
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: June 14, 2017