LiteTouch 1077183

GUDID 00383730000756

LiteTouch Medium Mask, Packaged

RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD

Medicine chamber spacer, reusable Medicine chamber spacer, reusable

• Primary Device ID: 00383730000756
• NIH Device Record Key: 54eebefd-db69-4cd1-9963-67d74ef2df0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LiteTouch
• Version Model Number: 00
• Catalog Number: 1077183
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	00383730000756 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100285

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: 2016-08-24

On-Brand Devices [LiteTouch]

• 00383730000800: liteTouch Large Mask, 10 pack.
• 00383730000794: LiteTouch Large Mask , ROW.
• 00383730000787: LiteTouch Large Mask Assembly, Polybag
• 00383730000770: LiteTouch Medium Mask, 10-pack.
• 00383730000763: LiteTouch Medium Mask, ROW.
• 00383730000756: LiteTouch Medium Mask, Packaged
• 00383730000749: LiteTouch Small Mask - ROW.
• 00383730000732: LiteTouch Small Mask, 10-pack.
• 00383730000725: LiteTouch Small Mask Assembly, Polybag