AccessGUDID - DEVICE: M SERIES BIPHASIC (00847946013080)

GUDID

Device Identifier (DI) Information

Brand Name: M SERIES BIPHASIC
Version or Model: 60010011100073011
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Zoll Medical Corporation

Primary DI Number: 00847946013080
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 055363428 *Terms of Use

Device Description: Defibrillator ,MAIN,EMTD-5,3/5 LEAD,BIPHASIC,RCD,SMR,W/VOICE,AC,DMST,REFURB

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?
17882	Physiologic-monitoring defibrillation system	An assembly of electrically-powered devices designed to defibrillate the heart that incorporates additional therapeutic and/or monitoring features intended to resuscitate and/or monitor a cardiac patient. It typically includes devices that enable manual and/or automated external defibrillation (a defibrillator) and one or more of the following: electrocardiogram (ECG) monitoring (electrocardiograph), noninvasive cardiac pacing (temporary pacemaker), cardioversion (CV), pulse oximetry (oximeter), invasive and/or noninvasive blood pressure monitoring, and end-tidal carbon dioxide (EtCO2) monitoring (i.e., a CO2 monitor). It may have data recording/printing capabilities.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MKJ	Automated external defibrillators (non-wearable)
DPS	ELECTROCARDIOGRAPH
DRO	PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
LDD	Dc-defibrillator, low-energy, (including paddles)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K990762	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
Handling Environment Temperature: between 0 and 55 Degrees Celsius
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: more than 0 KiloPascal
Storage Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 6.8" x 10.3" x 8.2"

Device Record Status

Public Device Record Key: 936c0b59-752f-4721-8103-3457b60a45fa
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 18, 2014

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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