OPTICHAMBER DIAMOND 1126537

GUDID 00383730003917

OPTICHAMBER DIAMOND WMED MASK CHINA (P10)

RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD

Medicine chamber spacer, reusable Medicine chamber spacer, reusable

• Primary Device ID: 00383730003917
• NIH Device Record Key: 1b627998-11f4-439a-babd-27fd9b45e199
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTICHAMBER DIAMOND
• Version Model Number: 00
• Catalog Number: 1126537
• Company DUNS: 220018415
• Company Name: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00383730003917 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110293

FDA Product Code

• CAF: NEBULIZER (DIRECT PATIENT INTERFACE)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-12
• Device Publish Date: 2017-05-12

On-Brand Devices [OPTICHAMBER DIAMOND]

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