| Primary Device ID | B286FHCDWC3618TLLH1 | 
| NIH Device Record Key | 28faaa79-a579-4db3-adf8-349de47a40d4 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | DUAL CHAMBER BLANKET/FLUID WARMER Overall Size 30” | 
| Version Model Number | FHCDWC36-18-TL-LH | 
| Catalog Number | FHCDWC36-18-TL-LH | 
| 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 | 
| Phone | (877) 828-9975 | 
| info@macmedical.com | |
| Phone | (877) 828-9975 | 
| info@macmedical.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | B286FHCDWC3618TLLH1 [Primary] | 
| LHC | Warmer, Irrigation Solution | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 3 | 
| Public Version Date | 2018-07-06 | 
| Device Publish Date | 2016-07-27 | 
| B286FHCDWC36TLLH2201 | Overall size 30”W x 26.5”D x 74.5”T. Upper Chamber I.D. 26”W x 23”D x 25”T 8.63 C | 
| B286FHCDWC36TLLH1 | Overall size 30”W x 26.5”D x 74.5”T. Upper Chamber I.D. 26”W x 23”D x 25”T 8.63 C | 
| B286FHCDWC3618TLLH2201 | Overall size 30”W x 20.5”D x 74.5”T. 18" Depth Digital control. Left Hand 4 Adjustable s | 
| B286FHCDWC3618TLLH1 | Overall size 30”W x 20.5”D x 74.5”T. 18" Depth Digital control. Left Hand 4 Adjustable s | 
| B286FHCDWC3618TL2201 | Overall size 30”W x 20.5”D x 74.5”T. 18" Depth Digital control. 4 Adjustable shelves. | 
| B286FHCDWC3618TL1 | Overall size 30”W x 20.5”D x 74.5”T. 18" Depth Digital control. 4 Adjustable shelves. |