FDA UDI
In Commercial Distribution
🇺🇸 United States
Invenio
DI: 16931918166308
·
Model: i49-RTK05
·
GRI Medical & Electronic Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Invenio
- Primary DI
- 16931918166308
- Version / Model
- i49-RTK05
- Company Name
- GRI Medical & Electronic Technology Co., Ltd.
- Labeler DUNS
- 679894738
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-02
- Public Version
- 1
- Public Version Date
- 2024-02-12
- Public Version Status
- New
- Public Device Record Key
- 6a78e422-1bd4-4c5f-9c1d-d7145c2dfe7e
Device Description
Room Turnaround Kit_Non Sterile_36ea/cs
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| KME | Bedding, Disposable, Medical | General Hospital | 880.6060 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65175 | Operating room turnover kit | A collection of devices intended to be used to efficiently clean and prepare an operating room (OR) for a subsequent surgical procedure. It typically includes patient oriented items such as absorbent covers/drapes for the operating table and patient positioners (e.g., headrest), operating room cleaning items such as cleaning mop heads and pads, and refuse containment items such as surgical waste and biohazard bags/buckets. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 26931918166305 | GS1 | 36 | In Commercial Distribution | ||
| Primary | 16931918166308 | GS1 |
Customer Contacts
- Phone
- +86057383617385
- [email protected]