FDA UDI
In Commercial Distribution
🇺🇸 United States
Neo Sheets(100 pcs/box)
DI: 04942962603379
·
Model: 60337
·
ATOM MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
5
Basic Information
- Brand Name
- Neo Sheets(100 pcs/box)
- Primary DI
- 04942962603379
- Version / Model
- 60337
- Catalog Number
- 60337
- Company Name
- ATOM MEDICAL CORPORATION
- Labeler DUNS
- 690632047
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 3
- Public Version Date
- 2019-01-29
- Public Version Status
- Update
- Public Device Record Key
- 320da13e-d56e-465b-aba5-835611e5026e
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KME | Bedding, Disposable, Medical | General Hospital | 880.6060 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35180 | Conductive bed mattress cover | A device made of soft, conductive material that is shaped to fit over a bed mattress to create a physical barrier to protect the mattress, prevent cross-contamination and the build-up of static electricity. This is a single-patient device that is used for a limited time, without laundering, until considered inappropriate for further use and then discarded (e.g., incinerated). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04942962603379 | GS1 | ||||
| Unit of Use | 84942962603375 | GS1 | ||||
| Package | 14942962603376 | GS1 | Box | 10 | In Commercial Distribution | |
| Package | 24942962603373 | GS1 | Box | 2 | In Commercial Distribution |
Customer Contacts
- Phone
- +81 488533661
- [email protected]