FDA UDI
In Commercial Distribution
🇺🇸 United States
RECESSED BLANKET/FLUID WARMER Overall Size 24”W x 20.5”D x 24.5”T
DI: B286FHCSWC1824TLGR1
·
Model: FHCSWC1824-TL-G-R
·
M.A.C. MEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RECESSED BLANKET/FLUID WARMER Overall Size 24”W x 20.5”D x 24.5”T
- Primary DI
- B286FHCSWC1824TLGR1
- Version / Model
- FHCSWC1824-TL-G-R
- Catalog Number
- FHCSWC1824-TL-G-R
- Company Name
- M.A.C. MEDICAL INC.
- Labeler DUNS
- 188660844
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-28
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 8926b1f2-99a3-4a6f-9336-7e3330132252
Device Description
RECESSED CABINET Overall size 24”W x 20.5”D x 6 x 24.5”T. Chamber I.D. 20”W x 17”D x 15.25”T. 3.0 Cubic ft. storage. Digital control. Optional adjustable shelve. Full view glass door. Audible and visual over-temp alarm. Accuracy +/- 1 degrees F. Electrical: 120V, 3.5 Amp, 50/60 Hz. .45kw/hr, 1537 btu/hr. UL/CUL listed. Key temperature lock. Foot levelers
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LHC | Warmer, Irrigation Solution | Physical Medicine | 890.5950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55829 | Blanket warming cabinet, dry-heat | A mains electricity (AC-powered) device designed to warm blankets with hot dry air. It is typically a high capacity (e.g., 0.2 to 0.5 m3) unit with appropriate perforated shelves for blanket positioning, avoiding contact with very hot surfaces to prevent scorching. Hot dry air is usually circulated to heat blankets in a temperature range from 30 to 90? C (90 to 200? F). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B286FHCSWC1824TLGR1 | HIBCC |
Customer Contacts
- Phone
- (877) 828-9975
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K080609 | 000 |