FDA UDI
In Commercial Distribution
🇺🇸 United States
STRETCHER WITH KNEE GATCH
DI: B286FHC7100KNEE1
·
Model: FHC7100-KNEE
·
M.A.C. MEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- STRETCHER WITH KNEE GATCH
- Primary DI
- B286FHC7100KNEE1
- Version / Model
- FHC7100-KNEE
- Catalog Number
- FHC7100-KNEE
- 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
- 2016-07-26
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 56a63df3-8b4d-4628-87e1-c6aad9c00cca
Device Description
MOBILECARE STRETCHER WITH KNEE GATCH. PNEUMATIC FOWLER ADJUSTMENT. HEIGHT ADJUST RANGE OF 23" TO 36". PEDALS LOCATED ON EITHER SIDE. +/- 18 DEGREE TRENDELENBURG AND REVERSE TRENDELEBURG, ADJUSTMENT PEDALS ON EITHER SIDE. FOLD FORWARD SIDE RAILS. BUILT IN O2 CYLINDER STORAGE. CENTRAL LOCKING CASTERS. BRAKE/STEER PEDALS LOCATED ON ALL 4 CORNERS. REMOVABLE 2 HOOK I.V. POLE AND 4" FOAM MATTRESS INCLUDED. WEIGHT CAPACITY 550LB
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
- Yes
- 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 |
|---|---|---|---|---|
| FPO | Stretcher, Wheeled | General Hospital | 880.6910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35892 | Hospital stretcher, manual | A manually-operated device consisting of a platform mounted on a wheeled frame designed primarily to facilitate easy transport of a recumbent patient within a healthcare facility; it may include side rails, supports for fluid infusion equipment, and patient securement straps. The device may also be used as a treatment table (e.g., in an emergency, recovery, or labour room), or as a bed in some intensive and specialized care units or under high patient census conditions (e.g., disasters). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B286FHC7100KNEE1 | HIBCC |
Customer Contacts
- Phone
- (877) 828-9975
- [email protected]