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Warmer, Single Chamber

FDA UDI

Class I (US FDA UDI)

by Mac Medical, Inc.

Identity

Trade Name
WARMER, SINGLE CHAMBER FDA UDI
Generic Name
Blanket warming cabinet, dry-heat FDA UDI
Device Name
Overall size 30”W x 26.5”D x 36”T. 8.63 Cubic ft. storage Chamber I.D. 26”W x 23”D x 25”T. Temperature Range: 90-160 F Accuracy +/- 2 degrees F of set point 2 Adjustable shelves Digital control Glass door Audible and visual over-temp alarm Keyed temperature lock Door lock Data logger Foot levelers 4" base Electrical: 120V, 7.5 Amp, 50/60 Hz .35 kw/hr, 1195 btu/hr UL/CUL listed FDA Regist FDA UDI
Model / Reference
SWC243036-G-4B FDA UDI
Description
Overall size 30”W x 26.5”D x 36”T. 8.63 Cubic ft. storage Chamber I.D. 26”W x 23”D x 25”T. Temperature Range: 90-160 F Accuracy +/- 2 degrees F of set point 2 Adjustable shelves Digital control Glass door Audible and visual over-temp alarm Keyed temperature lock Door lock Data logger Foot levelers 4" base Electrical: 120V, 7.5 Amp, 50/60 Hz .35 kw/hr, 1195 btu/hr UL/CUL listed FDA Regist FDA UDI

Identifiers

Catalog Number
SWC243036-G-4B FDA UDI
Primary DI / UDI-DI
B286SWC243036G4B1 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

Warmer, Single Chamber 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.

Cleared under the same submission

K080609 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mac Medical, Inc.

Sources (1)

  • FDA UDI 6be3e66e-e033-4d61-8154-734565ddc1fd 36 fields · synced May 30, 2026