| Primary Device ID | B286W1518XSS1 |
| NIH Device Record Key | 6daa9f85-b128-4708-b50b-1c6ef791267c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | COUNTER TOP/WALL MOUNT SINGLE CHAMBER BLANKET/FLUI |
| Version Model Number | W1518XSS |
| Catalog Number | W1518XSS |
| 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 | B286W1518XSS1 [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 | 2016-07-29 |
| 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 |