FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 04961333240982
·
Model: 80225
·
PENTAX OF AMERICA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 04961333240982
- Version / Model
- 80225
- Company Name
- PENTAX OF AMERICA, INC.
- Labeler DUNS
- 083211284
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-01
- Public Version
- 1
- Public Version Date
- 2018-04-02
- Public Version Status
- New
- Public Device Record Key
- ea68ed27-2250-4680-8b2c-2ad2eca8d5af
Device Description
PREC. COMPACT CART H37.5XW24XD
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| BZN | Cart, Emergency, Cardiopulmonary (Excluding Equipment) | Anesthesiology | 868.6175 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47080 | Endoscope transport trolley | A cart that is specially designed with dedicated instrument trays for the protective transport and short-term storage of endoscopes, their accessories, and other sensitive equipment. This trolley (cart) typically consists of a metal frame with plastic panels, and contains various numbers of platforms (e.g., trays that slot into the frame). It provides a safe and efficient environment for the organization of the endoscopes, minimizing their direct handling and contact with airborne contaminants, and allowing their visualization to distinguish those that have been sterilized from those that are contaminated. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04961333240982 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Depth | 24.6 | Inch | |
| Width | 24.0 | Inch | |
| Height | 37.5 | Inch |