ClearChest®

GUDID 00841561102334

Comfort Band, Large

RESPIRATORY TECHNOLOGIES, INC.

Chest-oscillation airway secretion-clearing system vest

• Primary Device ID: 00841561102334
• NIH Device Record Key: e8b51f26-045e-4a2b-bdb6-4c1369c63284
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearChest®
• Version Model Number: 100104-000
• 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	00841561102334 [Primary]
GS1	10841561102331 [Package]; Package: [6 Units]; In Commercial Distribution

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 [ClearChest®]

• 00841561102389: Comfort Band, UL, XLarge
• 00841561102372: Comfort Band, UL, Large
• 00841561102365: Comfort Band, UL, Medium
• 00841561102358: Comfort Band, UL, Small
• 00841561102341: Comfort Band, XLarge
• 00841561102334: Comfort Band, Large
• 00841561102327: Comfort Band, Medium
• 00841561102310: Comfort Band, Small
• 00841561102303: Comfort Vest, Size 60
• 00841561102297: Comfort Vest, Size 58
• 00841561102280: Comfort Vest, Size 56
• 00841561102211: Comfort Vest, Size 42
• 00841561102167: Comfort Vest, Size 32
• 00841561102150: Comfort Vest, Size 30
• 00841561102143: Comfort Vest, Size 28
• 00841561102136: Comfort Vest, Size 26
• 00841561102129: Comfort Vest, Size 24
• 00841561102112: Comfort Vest, Size 22
• 00841561102105: Comfort Vest, Size 20
• 00841561102099: Comfort Vest, Size 18
• 00841561102082: Comfort Vest, Size 16
• 00841561102273: Comfort Vest, Size 54
• 00841561102266: Comfort Vest, Size 52
• 00841561102259: Comfort Vest, Size 50
• 00841561102242: Comfort Vest, Size 48
• 00841561102235: Comfort Vest, Size 46
• 00841561102228: Comfort Vest, Size 44
• 00841561102204: Comfort Vest, Size 40
• 00841561102198: Comfort Vest, Size 38
• 00841561102181: Comfort Vest, Size 36
• 00841561102174: Comfort Vest, Size 34