ADULT MFE

GUDID 00847946016388

PD 2200 ADULT MULTI-FUNCTION ELECTRODES - 1 PAIR

BIO-DETEK INCORPORATED

Rechargeable professional automated external defibrillator
Primary Device ID00847946016388
NIH Device Record Key248f8013-3550-4f9c-90c9-39a0744bd99a
Commercial Distribution StatusIn Commercial Distribution
Brand NameADULT MFE
Version Model Number8900-2051
Company DUNS144116225
Company NameBIO-DETEK INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

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Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100847946016388 [Primary]
GS110847946016385 [Package]
Package: CASE [12 Units]
In Commercial Distribution

FDA Product Code

LDDDc-defibrillator, low-energy, (including paddles)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2014-09-24

On-Brand Devices [ADULT MFE]

00847946016432ADULT CATH LAB MULTI-FUNCTION ELECTRODES - 1 PAIR
00847946016388PD 2200 ADULT MULTI-FUNCTION ELECTRODES - 1 PAIR

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