Identity
- Trade Name
- WARMING CABINET, FDA UDI
- Generic Name
- Blanket warming cabinet, dry-heat FDA UDI
- Device Name
- Skytron Overall size 18”W x 15.5”D x 22”T. 1.4 Cubic ft. storage Chamber I.D. 14”W x 13"D x 13”T Temperature Range: 90-135 F Accuracy +/- 1 degrees F Digital control. Stainless steel door Audible and visual over-temp alarm. Keyed temperature lock for each chamber Data Logger Foot levelers Electrical: 120V, 3.5 Amp, 50/60 Hz. .39kw/hr, 1332 btu/hr. UL/CUL listed FDA Registered FDA UDI
- Model / Reference
- SKSWC1518-TL-D FDA UDI
- Description
- Skytron Overall size 18”W x 15.5”D x 22”T. 1.4 Cubic ft. storage Chamber I.D. 14”W x 13"D x 13”T Temperature Range: 90-135 F Accuracy +/- 1 degrees F Digital control. Stainless steel door Audible and visual over-temp alarm. Keyed temperature lock for each chamber Data Logger Foot levelers Electrical: 120V, 3.5 Amp, 50/60 Hz. .39kw/hr, 1332 btu/hr. UL/CUL listed FDA Registered FDA UDI
Identifiers
- Catalog Number
- SKSWC1518-TL-D FDA UDI
- Primary DI / UDI-DI
- B286SKSWC1518TLD1 FDA UDI
- 510(k) Number
- K080609 FDA UDI
- FDA Product Code
- LHC FDA UDI
- GMDN Term
- Blanket warming cabinet, dry-heat FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5950 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blanket warming cabinet, dry-heat
Warming Cabinet, by Mac Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blanket warming cabinet, dry-heat.
- DUAL CHAMBER BLANKET/FLUID WARMING CABINET Overall Size 30”W x 26.5”D x 74.5”T — FUTURE HEALTH CONCEPTS, INC. · Class I
- DUAL CHAMBER BLANKET/FLUID WARMING CABINET OVERALL DIMENSIONS 30 X 18 X 74.5 — FUTURE HEALTH CONCEPTS, INC. · Class I
- SINGLE CHAMBER WARMING CABINET — FUTURE HEALTH CONCEPTS, INC. · Class I
- COUNTER TOP BLANKET / FLUID WARMER Overall Size 24”W x 20.5”D x 24.5”T — FUTURE HEALTH CONCEPTS, INC. · Class I
- SINGLE CHAMBER BANKET/FLUID WARMING CABINET OUTSIDE DIMENSIONS 30”W x 26.5”D x 7 — FUTURE HEALTH CONCEPTS, INC. · Class I
- SINGLE CHAMBER BANKET/FLUID WARMING CABINET OUTSIDE DIMENSIONS 30”W x 26.5”D x 7 — FUTURE HEALTH CONCEPTS, INC. · Class I
- TRIPLE CHAMBER BLANKET/FLUID WARMING CABINET OVERALL SIZE 30 W X 26 1/2 D X 78 — FUTURE HEALTH CONCEPTS, INC. · Class I
- DUAL CHAMBER BLANKET / FLUID WARMER Overall Size 30”W x 26.5”D x 74.5”T — FUTURE HEALTH CONCEPTS, INC. · Class I
Cleared under the same submission
K080609 also covers:
- COUNTER TOP BLANKET / FLUID WARMER Overall Size 24”W x 20.5”D x 24.5”T — Mac Medical, Inc.
- COUNTER TOP BLANKET / FLUID WARMER Overall Size 30”W x 20.5”D x24.5”T — Mac Medical, Inc.
- COUNTER TOP BLANKET/FLUID WARMER Overall Size 24”W x 26.5”D x 24.5”T — Mac Medical, Inc.
- COUNTER TOP BLANKET/FLUID WARMER Overall Size 24”W x 26.5”D x 24.5”T — Mac Medical, Inc.
- COUNTER TOP BLANKET/FLUID WARMING CABINET OUTSIDE DIMENSIONS 24"W x 20.5"D x 24. — Mac Medical, Inc.
- COUNTER TOP/ WALL MOUNT SINGLE CHAMBER WARMING CABINET — Mac Medical, Inc.
- COUNTER TOP/WALL MOUNT SINGLE CHAMBER WARMER, 18 X 15.5 X 22 — Mac Medical, Inc.
- Counter Top Blanket/Fluid Warming Cabinet Outside Dimensions 30" W x 26.6"d x 24 — Mac Medical, Inc.
- Counter Top Blanket/Fluid Warming Cabinet Outside Dimensions 30" W x 26.6"d x 24 — Mac Medical, Inc.
- Counter Top Blanket/Fluid Warming Cabinet Overall size 30”W x 26.5”D x24.5”T — Mac Medical, Inc.
- DUAL CHAMBER BLANKET / FLUID WARMER Overall Size 24”W x 26.5”D x 74.5”T — Mac Medical, Inc.
- DUAL CHAMBER BLANKET / FLUID WARMER Overall Size 30”W x 20.5”D x 64.75”T — Mac Medical, 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 I | Pending data |
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Manufacturer
- Manufacturer
- Mac Medical, Inc.
Sources (1)
- FDA UDI a27c8835-3483-4e2c-a55d-dd1786a541da 36 fields · synced May 29, 2026