Identity
- Trade Name
- inCourage® FDA UDI
- Generic Name
- Utility trolley FDA UDI
- Device Name
- Facility Cart, Cool Grey FDA UDI
- Model / Reference
- 500040-001 FDA UDI
- Description
- Facility Cart, Cool Grey FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841561102792 FDA UDI
- 510(k) Number
- K051383 FDA UDI
- FDA Product Code
- BYI FDA UDI
- GMDN Term
- Utility trolley FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5665 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Utility trolley
inCourage® by Respiratory Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Utility trolley.
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- Ventilator Trolley — BREAS MEDICAL, INC. · Class I
Cleared under the same submission
K051383 also covers:
- ClearChest® — RESPIRATORY TECHNOLOGIES, INC.
- ClearChest® — RESPIRATORY TECHNOLOGIES, INC.
- ClearChest® — RESPIRATORY TECHNOLOGIES, INC.
- ClearChest® — RESPIRATORY TECHNOLOGIES, INC.
- ClearChest® — RESPIRATORY TECHNOLOGIES, INC.
- ClearChest® — RESPIRATORY TECHNOLOGIES, INC.
- InCourage® — RESPIRATORY TECHNOLOGIES, INC.
- InCourage® — RESPIRATORY TECHNOLOGIES, INC.
- InCourage® — RESPIRATORY TECHNOLOGIES, INC.
- InCourage® — RESPIRATORY TECHNOLOGIES, INC.
- inCourage® — RESPIRATORY TECHNOLOGIES, INC.
- inCourage® — RESPIRATORY TECHNOLOGIES, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Respiratory Technologies, Inc.
Sources (1)
- FDA UDI b3e41ae7-a151-4c10-b081-53d96da6535d 35 fields · synced May 31, 2026