Antistatic Compact Space Chamber with Small Mask

GUDID 10842135100012

MEDICAL DEVELOPMENTS INTERNATIONAL LIMITED

Medicine chamber spacer, reusable
Primary Device ID10842135100012
NIH Device Record Key33d584ef-f2ec-4eeb-bacb-53b6d6ce876d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAntistatic Compact Space Chamber with Small Mask
Version Model NumberSP-ANTI-SSUS
Company DUNS751908968
Company NameMEDICAL DEVELOPMENTS INTERNATIONAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100842135100015 [Primary]
GS110842135100012 [Package]
Contains: 00842135100015
Package: Outer Carton [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NVPHolding Chambers, Direct Patient Interface

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 Date2017-04-13

On-Brand Devices [Antistatic Compact Space Chamber with Small Mask]

10842135100012SP-ANTI-SSUS
00842135100015SP-ANTI-SSUS

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