| Primary Device ID | B286FHCSWC1518TLD1 | 
| NIH Device Record Key | 96f6c01e-39ef-4535-9917-e150d17d7e5f | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | COUNTER TOP/WALL MOUNT SINGLE CHAMBER BLANKET/FLUI | 
| Version Model Number | FHCSWC1518-TL-D | 
| Catalog Number | FHCSWC1518-TL-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 | 
| Phone | (877) 828-9975 | 
| info@macmedical.com | |
| Phone | (877) 828-9975 | 
| info@macmedical.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | B286FHCSWC1518TLD1 [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 | 2016-07-28 | 
| B286W1518XSS1 | 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 | 
| B286SWC151822NB1 | 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 | 
| B286SWC151822GNB1 | 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 | 
| B286FHCSWC1518TLD1 | 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 |