COUNTER TOP/WALL MOUNT BLANKET/FLUID WARMING CABIN FHCSWC1518-TL-G-D

GUDID B286FHCSWC1518TLGD1

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 Dat

M.A.C. MEDICAL INC.

Blanket warming cabinet, dry-heat

• Primary Device ID: B286FHCSWC1518TLGD1
• NIH Device Record Key: 045abbd9-8a64-4f3d-a443-25201c552bef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COUNTER TOP/WALL MOUNT BLANKET/FLUID WARMING CABIN
• Version Model Number: FHCSWC1518-TL-G-D
• Catalog Number: FHCSWC1518-TL-G-D
• Company DUNS: 188660844
• Company Name: M.A.C. MEDICAL 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (877) 828-9975
• Email: info@macmedical.com
• Phone: (877) 828-9975
• Email: info@macmedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B286FHCSWC1518TLGD1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080609

FDA Product Code

• LHC: Warmer, Irrigation Solution

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-28

On-Brand Devices [COUNTER TOP/WALL MOUNT BLANKET/FLUID WARMING CABIN]

• B286FHCSWC1518TLLH2201: Overall size 18”W x 15.5”D x 6 x 22”T. Chamber I.D. 14”W x 13”D x 13”T. 1.4 Cubic
• B286FHCSWC1518TLLH1: Overall size 18”W x 15.5”D x 6 x 22”T. Chamber I.D. 14”W x 13”D x 13”T. 1.4 Cubic
• B286FHCSWC1518TLGLH2201: Overall size 18”W x 15.5”D x 6 x 22”T. Chamber I.D. 14”W x 13”D x 13”T. 1.4 Cubic
• B286FHCSWC1518TLGLH1: Overall size 18”W x 15.5”D x 6 x 22”T. Chamber I.D. 14”W x 13”D x 13”T. 1.4 Cubic
• B286FHCSWC1518TLGDEMO1: 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
• B286FHCSWC1518TLGD1: 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
• B286FHCSWC1518TLG2201: Overall size 18”W x 15.5”D x 22”T. Chamber I.D. 14”W x 13”D x 13”T. 1.4 Cubic ft.
• B286FHCSWC1518TLG1: 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
• B286FHCSWC1518TL2201: Overall size 18”W x 15.5”D x 22”T. Chamber I.D. 14”W x 13”D x 13”T. 1.4 Cubic ft.
• B286FHCSWC1518TL1: 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