FDA UDI
In Commercial Distribution
🇺🇸 United States
Take-Out
DI: 10724995180345
·
Model: 00711760
·
US Endoscopy
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- Take-Out
- Primary DI
- 10724995180345
- Version / Model
- 00711760
- Catalog Number
- 00711760
- Company Name
- US Endoscopy
- Labeler DUNS
- 627879687
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2021-03-31
- Public Version
- 1
- Public Version Date
- 2021-04-08
- Public Version Status
- New
- Public Device Record Key
- 2b0de403-cdc4-4c9f-8c35-0181e1eecb4d
Device Description
The Takeout Transport Pad is a safe way to transport an endoscope to the reprocessing room after use.
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMH | CONTAINER, SPECIMEN, STERILE | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12535 | Medical equipment drape, single-use | A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00724995180348 | GS1 | ||||
| Primary | 10724995180345 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]