FDA UDI
In Commercial Distribution
🇺🇸 United States
JEDMED
DI: M6330415700
·
Model: 04-1570
·
JEDMED INSTRUMENT COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- JEDMED
- Primary DI
- M6330415700
- Version / Model
- 04-1570
- Catalog Number
- 04-1570
- Company Name
- JEDMED INSTRUMENT COMPANY
- Labeler DUNS
- 092987189
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-17
- Public Version
- 1
- Public Version Date
- 2018-08-17
- Public Version Status
- New
- Public Device Record Key
- 3c3774cf-8e60-4887-a133-a07535f8f20c
Device Description
"L" Chair Manual Base
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| FRK | Chair, Examination And Treatment | General Hospital | 880.6140 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47147 | ENT chair, mechanical | A manually- or hydraulically-powered device designed to support a patient in a seated position to facilitate ear, nose, throat (i.e., ENT) examination, treatment, and/or minor surgery. It is typically adjustable in height to enable healthcare staff to perform procedures while standing. It usually includes head and armrests, a reclining back that may be tilted from a vertical to a horizontal position, and has rotating capabilities; some types can be programmed to standard positions. Devices intended for ENT examination and/or treatment (e.g., otoscopes, laryngoscopes) may be attached as components of the chair, or stand separately as self-supported, wall- or ceiling-mounted units. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M6330415700 | HIBCC |
Customer Contacts
- Phone
- 314-845-3770
- [email protected]