| Primary Device ID | B286SWC243036G2BC1 | 
| NIH Device Record Key | 6c9e0673-6e3e-461b-8380-86a0a27432ac | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | WARMER, SINGLE CHAMBER | 
| Version Model Number | SWC243036-G-2B-C | 
| Catalog Number | SWC243036-G-2B-C | 
| 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 | B286SWC243036G2BC1 [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 | 2016-08-01 | 
| 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 |