DUAL CHAMBER BLANKET / FLUID WARMER Overall Size 24”W x 26.5”D x 74.5”T

FDA UDI

Class I (US FDA UDI)

by Mac Medical, Inc.

Identity

Trade Name: DUAL CHAMBER BLANKET / FLUID WARMER Overall Size 24”W x 26.5”D x 74.5”T FDA UDI
Generic Name: Blanket warming cabinet, dry-heat FDA UDI
Device Name: Overall size 24”W x 26.5”D x 74.5”T. 15.95 Cubic ft. storage Upper Chamber I.D. 20”W x 23”D x 15.25”T 4.05 Cubic ft. storage Temperature Range: 90-160 F Accuracy +/- 1 degrees F of set point Lower Chamber I.D. 20”W x 23”D x 34.5”T 11.9 Cubic ft. storage Temperature Range: 90-160 F Accuracy +/- 3 degrees F of set point 3 Adjustable shelves Digital control Stainless steel doors Audible and visual over-temp alarm Electrical: 120V, 7.5 Amp, 50/60 Hz .46 kw/hr, 1570 btu/hr UL/CUL listed FDA Registered MOBILE BASE FDA UDI
Model / Reference: FHCDWC2424-TL-MB FDA UDI
Description: Overall size 24”W x 26.5”D x 74.5”T. 15.95 Cubic ft. storage Upper Chamber I.D. 20”W x 23”D x 15.25”T 4.05 Cubic ft. storage Temperature Range: 90-160 F Accuracy +/- 1 degrees F of set point Lower Chamber I.D. 20”W x 23”D x 34.5”T 11.9 Cubic ft. storage Temperature Range: 90-160 F Accuracy +/- 3 degrees F of set point 3 Adjustable shelves Digital control Stainless steel doors Audible and visual over-temp alarm Electrical: 120V, 7.5 Amp, 50/60 Hz .46 kw/hr, 1570 btu/hr UL/CUL listed FDA Registered MOBILE BASE FDA UDI

Identifiers

Catalog Number: FHCDWC2424-TL-MB FDA UDI
Primary DI / UDI-DI: B286FHCDWC2424TLMB1 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Blanket warming cabinet, dry-heat

DUAL CHAMBER BLANKET / FLUID WARMER Overall Size 24”W x 26.5”D x 74.5”T by Mac Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID

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

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 c042516d-c561-4f9c-8124-04bbf9c11ead 36 fields · synced Jun 1, 2026