| Primary Device ID | M689BH01010 |
| NIH Device Record Key | b984f929-43d5-4801-ad95-c6e31613284c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Blizzard Casualty Blanket XL + Heat pads |
| Version Model Number | 1 |
| Catalog Number | BH-01 |
| Company DUNS | 118492643 |
| Company Name | Safeguard US Operating, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M689BH01010 [Primary] |
| IMD | Pack, Hot Or Cold, Disposable |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-14 |
| Device Publish Date | 2025-01-06 |
| M6892500301010 - SAVeII+ Starter Bundle, 3-Patient – Basic | 2025-03-06 SAVe II+™ accessories. |
| M6892501001010 - SAVeII+ Starter Bundle, 10-Patient – Basic | 2025-03-06 SAVe II+™ accessories. |
| M68980801D140 - Fresh Whole Blood Donor Transfusion Set | 2025-03-05 The Fresh Whole Blood Donor Set contains everything needed to properly document donor information, screen for ABO/Rh, collect sa |
| M68955110020 - PRO PELVIC SPLINT | 2025-02-27 PRO PELVIC SPLINT 1 ea - 6 mm Neoprene Band, 1 ea - Black Velcro Straps with Buckle Intended for the emergency management of sus |
| M6898130301110 - MARCH IFAK RESUPPLY | 2025-02-27 The MARCH™ IFAK Resupply bundle is intended to be used as resupply for the US Army standard IFAK or similar commercial applica |
| M68980110110 - SALINE LOCK KIT | 2025-02-03 18 GA. Catheter 1 ea 20 GA. Catheter 1 ea Saline Flush (5cc pre-filled syringe) 1 ea Povidone |
| M68924100070 - Poolside Medical Rescue Set | 2025-01-20 Set provides medical support for bleeding control and wound care to facilitate injuries that may happen in or around pools, or a |
| M6898011010040 - 80-110-10 Saline Lock Kit Case of 10 | 2025-01-20 The Mojo® Saline Lock Kit allows for quick and effective extremity venous cannulation under the most demanding conditions in on |