WARMER, SINGLE CHAMBER SWC243036-G-MS

GUDID B286SWC243036GMS1

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

M.A.C. MEDICAL INC.

Blanket warming cabinet, dry-heat

• Primary Device ID: B286SWC243036GMS1
• NIH Device Record Key: b32c925e-7c10-4a2c-a668-31ef6fd11775
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WARMER, SINGLE CHAMBER
• Version Model Number: SWC243036-G-MS
• Catalog Number: SWC243036-G-MS
• 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	B286SWC243036GMS1 [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: 2016-08-01

On-Brand Devices [WARMER, SINGLE CHAMBER]

• B286SWC243036MB1: 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 2
• B286SWC243036GMS1: 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 2
• B286SWC243036GMB1: 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 2
• B286SWC243036GLHMB1: Overall size 30”W x 26.5”D x 6 x 36”T. Chamber I.D. 26”W x 23”D x 25”T. 8.63 Cubi
• B286SWC243036GLH2B1: Overall size 30”W x 26.5”D x 6 x 36”T. Chamber I.D. 26”W x 23”D x 25”T. 8.63 Cubi
• B286SWC243036G4B1: 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 2
• B286SWC243036G2BC1: Overall size 30”W x 26.5”D x 6 x 36”T. Chamber I.D. 26”W x 23”D x 25”T. 8.63 Cubi
• B286SWC243036G2B1: 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 2
• B286SWC2430362B1: 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 2