Defibtech ACC Wrist Straps

GUDID 20815098020687

DEFIBTECH, L.L.C.

Cardiac resuscitator, line-powered
Primary Device ID20815098020687
NIH Device Record Keyf7fcb3e5-66eb-4037-82eb-84d78e1ea2fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameDefibtech ACC Wrist Straps
Version Model NumberRSS-1010
Company DUNS128340200
Company NameDEFIBTECH, L.L.C.
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815098020669 [Primary]
GS110815098020673 [Package]
Contains: 00815098020669
Package: domestic configurati [1 Units]
In Commercial Distribution
GS110815098020680 [Package]
Contains: 00815098020669
Package: export configuration [1 Units]
In Commercial Distribution
GS120815098020670 [Package]
Contains: 00815098020669
Package: domestic configurati [3 Units]
In Commercial Distribution
GS120815098020687 [Package]
Contains: 00815098020669
Package: export configuration [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRMCompressor, Cardiac, External

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-05-19

Devices Manufactured by DEFIBTECH, L.L.C.

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