FDA UDI
In Commercial Distribution
🇺🇸 United States
TOM2 Pediatric Gel Crib Mattress Family
DI: 00845699008100
·
Model: Pediatric Gel Crib Pad Family
·
SIZEWISE RENTALS, L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TOM2 Pediatric Gel Crib Mattress Family
- Primary DI
- 00845699008100
- Version / Model
- Pediatric Gel Crib Pad Family
- Company Name
- SIZEWISE RENTALS, L.L.C.
- Labeler DUNS
- 967025602
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-05
- Public Version
- 1
- Public Version Date
- 2021-03-15
- Public Version Status
- New
- Public Device Record Key
- 2536114b-b4ac-41c8-96a4-ad89ebe7aadb
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
- MR Safe
- 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 |
|---|---|---|---|---|
| FNM | Mattress, Air Flotation, Alternating Pressure | General Hospital | 880.5550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63641 | Alternating-pressure bed mattress | A mattress-like device consisting of an arrangement of alternating-pressure air cells designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie, rest, and sleep, and intended to distribute body weight over a large surface area typically to help relieve pressure points for comfort and improve blood circulation to prevent pressure sores. It is connected to an alternating-pressure pump (not included) which provides the inflation/deflation control. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers) patients, patients with disabilities, or patients with low body fat. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00845699008100 | GS1 |
Customer Contacts
- Phone
- 951-273-7888
- [email protected]