OPTICHAMBER DIAMOND 1126536

GUDID 00383730003924

OPTICHAMBER DIAMOND WLG MASK CHINA (P10)

RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD

Medicine chamber spacer, reusable
Primary Device ID00383730003924
NIH Device Record Keyfba6c3dd-e80d-4533-b318-5876faa8c3e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPTICHAMBER DIAMOND
Version Model Number00
Catalog Number1126536
Company DUNS220018415
Company NameRESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com
Phone+1(724)744-2500
Emailrespironics.service@philips.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100383730003924 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAFNEBULIZER (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 Date2018-11-12
Device Publish Date2017-05-12

On-Brand Devices [OPTICHAMBER DIAMOND]

00383730003924OPTICHAMBER DIAMOND WLG MASK CHINA (P10)
00383730003917OPTICHAMBER DIAMOND WMED MASK CHINA (P10)
00383730003900OPTICHAMBER DIAMOND WSMALL MASK CHINA (P10)
00383730003894OPTICHAMBER DIAMOND CHINA (P10)
00383730000633ASTHMAPACK FOR CHILDREN, 10-Pack
00383730000626ASTHMA PACK FOR ADULTS, 10 Pack
00383730000527DIAMOND WITH MED MASK-PREFERRED PLUS
00383730000510DIAMOND WITH LG MASK-PREFERRED PLUS
00383730000503DIAMOND WITH SM MASK-PREFERRED PLUS
00383730000497DIAMOND-PREFERRED PLUS
00383730000381OPTICHAMBER DIAMOND WMED MASK (RUSSIA)
00383730000374OPTICHAMBER DIAMOND WSML MASK (RUSSIA)
00383730000350OPTICHAMBER DIAMOND W LG MASK CANADA
00383730000343OPTICHAMBER DIAMOND W MED MASK CANADA
00383730000336OPTICHAMBER DIAMOND W SM MASK- CANADA
00383730000329OPTICHAMBER DIAMOND - 10-PACK CANADA
00383730000268OC DIAMOND 50 PACK
00383730000251OPTICHAMBER DIAMOND W LRG MSK- ROW
00383730000244OC DIAMOND W LARGE MASK 10 PK- US
00383730000220OC DIAMOND W MEDIUM MASK 10 PK- US
00383730000213OPTICHAMBER DIAMOND W MED MSK- ROW
00383730000206OC DIAMOND W SMALL MASK 10 PK- US
00383730000190OPTICHAMBER DIAMOND W SMALL MASK- ROW
00383730000183OPTICHAMBER DIAMOND - ROW
00383730000176OPTICHAMBER DIAMOND - 10 PACK
00383730000145OptiChamber Diamond Anti-Static Valved Holding Chamber

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