FDA UDI
In Commercial Distribution
🇺🇸 United States
Enterprise
DI: 05055982758635
·
Model: 9821AC111ABUSA
·
Arjohuntleigh AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Enterprise
- Primary DI
- 05055982758635
- Version / Model
- 9821AC111ABUSA
- Catalog Number
- 9821AC111ABUSA
- Company Name
- Arjohuntleigh AB
- Labeler DUNS
- 355804758
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-15
- Public Version
- 1
- Public Version Date
- 2024-10-23
- Public Version Status
- New
- Public Device Record Key
- 919563b1-019e-4cf4-bd43-81f431eb0ee5
Device Description
Medical Bed - Enterprise - E9800X
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| FNL | BED, AC-POWERED ADJUSTABLE HOSPITAL | General Hospital | 880.5100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34870 | Basic electric hospital bed | A mains electricity (AC-powered) bed designed to be used as a patient bed for rest/sleep in a hospital ward/room, and which is motorized providing the patient/nursing staff with touch button adjustment possibilities. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard, siderails, and a remote control to operate the electrical motors. It may have an integrated weighing scale. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055982758635 | GS1 |
Customer Contacts
- Phone
- 1(800) 323-1245
- [email protected]