FDA UDI
In Commercial Distribution
🇺🇸 United States
AIR-MATT
DI: 00854564008183
·
Model: AM34DE
·
AIR-MATT INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- AIR-MATT
- Primary DI
- 00854564008183
- Version / Model
- AM34DE
- Company Name
- AIR-MATT INCORPORATED
- Labeler DUNS
- 079811425
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-20
- Public Version
- 1
- Public Version Date
- 2018-09-20
- Public Version Status
- New
- Public Device Record Key
- f8108e4a-f317-49ea-8eac-b6ab1124eee6
Device Description
AIR-MATT 34"/86CM WIDE X 78"/198CM LONG SPU
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| FMR | Device, Transfer, Patient, Manual | General Hospital | 880.6785 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37160 | Patient transfer system, powered | A mains electricity (AC-powered) assembly of devices used to transfer a supine patient, typically from his/her bed or transport stretcher to an operating table or vice versa. It is usually installed in large operating room (OR) complexes and serves as a sluice providing demarkation between the OR staff and the ward staff/porters and related devices. It may be designed as a motorized belt that is wider than the length of the patient and that rotates around a moveable pick-up plate which feeds in under the patient, drawing him/her onto the belt and depositing him/her onto an adjacent surface. It is typically fully automated, requiring no human intervention other than to operate the controls. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20854564008187 | GS1 | case (2 boxes) | 2 | In Commercial Distribution | |
| Package | 10854564008180 | GS1 | Box of 10 | 10 | In Commercial Distribution | |
| Primary | 00854564008183 | GS1 |
Customer Contacts
- Phone
- 1-800-466-2260
- [email protected]