inCourage®

GUDID 00841561102655

Wrap, Large, Northern Lights

RESPIRATORY TECHNOLOGIES, INC.

Chest-oscillation airway secretion-clearing system vest

• Primary Device ID: 00841561102655
• NIH Device Record Key: 6ae2829e-af56-474f-ae38-a62f211619c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: inCourage®
• Version Model Number: 137022-008
• Company DUNS: 847990566
• Company Name: RESPIRATORY TECHNOLOGIES, INC.
• 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: 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: 1-800-793-1261
• Email: xx@xx.xx

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841561102655 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051383

FDA Product Code

• BYI: Percussor, Powered-Electric

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2016-09-10

On-Brand Devices [inCourage®]

• 00841561102808: Pulsating Therapy Unit
• 00841561102785: Pulsating Therapy Unit
• 00841561102778: Pulsating Therapy Unit
• 00841561102747: Wrap, XLarge, Northern Lights
• 00841561102730: Wrap, XLarge, Pink Camo
• 00841561102723: Wrap, XLarge, Pixel Puzzle
• 00841561102716: Wrap, XLarge, Star Galaxy
• 00841561102709: Wrap, XLarge, Flower Power
• 00841561102693: Wrap, XLarge, Wild Camo
• 00841561102686: Wrap, XLarge, Pink Cloud
• 00841561102679: Wrap, XLarge, Blue Blizzard
• 00841561102662: Wrap, XLarge, Jet Black
• 00841561102655: Wrap, Large, Northern Lights
• 00841561102648: Wrap, Large, Pink Camo
• 00841561102631: Wrap, Large, Pixel Puzzle
• 00841561102624: Wrap, Large, Star Galaxy
• 00841561102617: Wrap, Large, Flower Power
• 00841561102600: Wrap, Large, Wild Camo
• 00841561102594: Wrap, Large, Pink Cloud
• 00841561102587: Wrap, Large, Blue Blizzard
• 00841561102570: Wrap, Large, Jet Black
• 00841561102563: Wrap, Medium, Northern Lights
• 00841561102556: Wrap, Medium, Pink Camo
• 00841561102549: Wrap, Medium, Pixel Puzzle
• 00841561102532: Wrap, Medium, Star Galaxy
• 00841561102525: Wrap, Medium, Flower Power
• 00841561102518: Wrap, Medium, Wild Camo
• 00841561102501: Wrap, Medium, Pink Cloud
• 00841561102495: Wrap, Medium, Blue Blizzard
• 00841561102488: Wrap, Medium, Jet Black
• 00841561102471: Wrap, Small, Northern Lights
• 00841561102440: Wrap, Small, Star Galaxy
• 00841561102433: Wrap, Small, Flower Power
• 00841561102402: Wrap, Small, Blue Blizzard
• 00841561102396: Wrap, Small, Jet Black
• 00841561102075: Vest, Size 60, Northern Lights
• 00841561102068: Vest, Size 60, Pink Camo
• 00841561102051: Vest, Size 60, Pixel Puzzle
• 00841561102044: Vest, Size 60, Star Galaxy
• 00841561102037: Vest, Size 60, Flower Power
• 00841561102020: Vest, Size 60, Wild Camo
• 00841561102013: Vest, Size 60, Pink Cloud
• 00841561102006: Vest, Size 60, Blue Blizzard
• 00841561101993: Vest, Size 60, Jet Black
• 00841561101986: Vest, Size 58, Northern Lights
• 00841561101979: Vest, Size 58, Pink Camo
• 00841561101962: Vest, Size 58, Pixel Puzzle
• 00841561101955: Vest, Size 58, Star Galaxy
• 00841561101948: Vest, Size 58, Flower Power
• 00841561101931: Vest, Size 58, Wild Camo