FDA UDI
In Commercial Distribution
🇺🇸 United States
La-Z-Boy Healthcare | Knu Comfort
DI: G53350470
·
Model: Durable 650 Series
·
Knu, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- La-Z-Boy Healthcare | Knu Comfort
- Primary DI
- G53350470
- Version / Model
- Durable 650 Series
- Catalog Number
- 5047
- Company Name
- Knu, LLC
- Labeler DUNS
- 197589893
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-27
- Public Version
- 1
- Public Version Date
- 2023-10-05
- Public Version Status
- New
- Public Device Record Key
- 3c24e1f8-4d63-40a7-bbd8-0cd4a30c12ad
Device Description
Mobile Healthcare Recliner - Removable Arm
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 |
|---|---|---|---|---|
| KMN | Chair And Table, Medical | General Hospital | 880.6140 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38448 | General examination/treatment chair, manual | A manually-operated 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. 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 | G53350470 | HIBCC |