FDA UDI
In Commercial Distribution
🇺🇸 United States
COUNTER TOP/WALL MOUNT SINGLE CHAMBER BLANKET/FLUID WARMER
DI: B286SWC151822NB1
·
Model: SWC151822-NB
·
M.A.C. MEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- COUNTER TOP/WALL MOUNT SINGLE CHAMBER BLANKET/FLUID WARMER
- Primary DI
- B286SWC151822NB1
- Version / Model
- SWC151822-NB
- Catalog Number
- SWC151822-NB
- 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
- 2016-08-01
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 8106fe86-ab9a-49db-88eb-a6d3c810e96e
Device Description
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”T Temperature Range: 90-135 F Accuracy +/- 1 degrees F Digital control. Audible and visual over-temp alarm. Keyed temperature lock for each chamber Data Logger Locking door Foot levelers Electrical: 120V, 3.5 Amp, 50/60 Hz. .39kw/hr, 1332 btu/hr. UL/CUL listed FDA Registered
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 | B286SWC151822NB1 | HIBCC |
Customer Contacts
- Phone
- (877) 828-9975
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K080609 | 000 |