FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00724995183479
·
Model: 710202
·
US Endoscopy
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00724995183479
- Version / Model
- 710202
- Catalog Number
- 710202
- Company Name
- US Endoscopy
- Labeler DUNS
- 627879687
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-24
- Public Version
- 1
- Public Version Date
- 2022-07-04
- Public Version Status
- New
- Public Device Record Key
- 77055082-e73b-4103-8573-7a2f96155bdf
Device Description
Suction Polyp Trap provides four capture chambers with large numbering to aid in accurate identification and localization of collected specimen.
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
- Yes
- 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 |
|---|---|---|---|---|
| KDQ | BOTTLE, COLLECTION, VACUUM | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43651 | General specimen receptacle transport container | A non-sterile, portable device designed for the transportation of one or multiple clinical specimen receptacles (e.g., glass vials, bottles, tubes, slides, swabs) from the point of collection to the laboratory or between medical institutions. It is typically designed to be liquid-tight with a shock-absorbing foam liner to protect the contents from adverse conditions that could cause breakage and to absorb any escaped fluid. It is available in a variety of sizes, shapes, and materials. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10724995183476 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 00724995183479 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 70 Degrees Celsius