FDA UDI
In Commercial Distribution
🇺🇸 United States
Midmark
DI: 00841709109676
·
Model: 626-006
·
MIDMARK CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Midmark
- Primary DI
- 00841709109676
- Version / Model
- 626-006
- Catalog Number
- 626-006
- Company Name
- MIDMARK CORPORATION
- Labeler DUNS
- 005036025
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-04
- Public Version
- 5
- Public Version Date
- 2022-02-18
- Public Version Status
- Update
- Public Device Record Key
- d797a32d-752e-4bd1-a115-fc0a6839ded4
Device Description
The examination table is intended to be used as a chair / table to provide positioning and support of patients during general examination procedures conducted by medical professionals. With the addition of the integrated digital scale, the examination table is additionally intended to be used for regular monitoring to assess patient weight change, as well as measuring patient weight to assist medical diagnosis. The integrated digital scale is not intended to be used for patients that weigh less than 30 pounds (13.6 kilograms) or more than 650 pounds (295 kilograms).
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
- Yes
- 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 |
|---|---|---|---|---|
| GBB | CHAIR, SURGICAL, AC-POWERED | General, Plastic Surgery | 878.4960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38447 | General examination/treatment chair, electric | A mains electricity (AC-powered) device designed to support and position the patient in a seated or reclined posture for easy access and patient comfort during a diagnostic examination, medical treatment, and/or surgical procedure across specialties. It usually has moveable components and may include special features such as a raising and lowering mechanism and removable arms; it may have an integrated weighing scale. For chairs involving the use of medical systems that emit and/or detect energy (e.g., ionizing or non-ionizing radiation, ultrasound, heat, light) see the respective chair terms for those systems. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841709109676 | GS1 |
Customer Contacts
- Phone
- +1(800)643-6275
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -30 – 60 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – 60 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity