FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00724995180386
·
Model: 710304
·
US Endoscopy
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00724995180386
- Version / Model
- 710304
- Catalog Number
- 710304
- Company Name
- US Endoscopy
- Labeler DUNS
- 627879687
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-02
- Public Version
- 4
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- ca369515-a747-4da2-93bb-3ef1a03a8c75
Device Description
The CO2 insufflator tubing set is used in the gastrointestinal tract with the STERIS CO2 endoscopic insufflators.
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| FCX | INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60738 | Endoscopic insufflation tubing set, single-use | A collection of flexible tubing intended to channel medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10724995180383 | GS1 | Case | 24 | In Commercial Distribution | |
| Primary | 00724995180386 | GS1 | ||||
| Previous | 00816765013113 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry