FDA UDI
In Commercial Distribution
🇺🇸 United States
DUAL CHAMBER BLANKET/FLUID WARMER, GLASS DOOR
DI: B286FHCDWC36TLGDSTLH1
·
Model: FHCDWC36-TL-G-D-ST-LH
·
M.A.C. MEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DUAL CHAMBER BLANKET/FLUID WARMER, GLASS DOOR
- Primary DI
- B286FHCDWC36TLGDSTLH1
- Version / Model
- FHCDWC36-TL-G-D-ST-LH
- Catalog Number
- FHCDWC36-TL-G-D-ST-LH
- 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
- 2016-07-27
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 4a1078e0-1d94-4344-adcb-35a3f91a7edf
Device Description
Overall size 30”W x 26.5”D x 79.5”T. 17.59 Cubic ft. storage 4 Adjustable shelves. Upper Chamber I.D. 26”W x 23”D x 25”T 8.63 Cubic ft. storage. Temperature Range: 90-160 F Accuracy +/- 2 degrees F Lower chamber I.D. 26 “W x 23”D x 26”T 8.96 Cubic ft. storage. Temperature Range: 90-160 F Accuracy +/- 2 degrees F Data Logger Digital control. Glass doors. Audible and visual over-temp alarm. Keyed temperature lock for each chamber Left hand hinge Slope top Foot levelers Electrical: 120V, 12 Amp, 50/60 Hz. 69kw/hr, 2356 btu/hr.
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 | B286FHCDWC36TLGDSTLH1 | HIBCC |
Customer Contacts
- Phone
- (877) 828-9975
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K080609 | 000 |