FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Gendron
DI: M368G16001
·
Model: G1600
·
GF HEALTH PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Gendron
- Primary DI
- M368G16001
- Version / Model
- G1600
- Catalog Number
- G1600
- Company Name
- GF HEALTH PRODUCTS, INC.
- Labeler DUNS
- 132016168
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-10
- Public Version
- 2
- Public Version Date
- 2025-10-24
- Public Version Status
- Update
- Public Device Record Key
- 7aaffa9f-0c16-4a40-9b84-d1f6b671fb99
- Distribution End Date
- 2021-01-10
Device Description
Stretcher, Bariatric
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 | M368G16001 | HIBCC |
Customer Contacts
- Phone
- 770-368-4700
- [email protected]