FDA UDI
In Commercial Distribution
🇺🇸 United States
Alleset
DI: 16931918171258
·
Model: C-2015-NS
·
GRI Medical & Electronic Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
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Basic Information
- Brand Name
- Alleset
- Primary DI
- 16931918171258
- Version / Model
- C-2015-NS
- Company Name
- GRI Medical & Electronic Technology Co., Ltd.
- Labeler DUNS
- 679894738
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2025-12-09
- Public Version
- 1
- Public Version Date
- 2025-12-17
- Public Version Status
- New
- Public Device Record Key
- 23b09549-f40c-47ac-8b3e-1bf71c6d63dc
Device Description
Insufflation Tubing-micron Hi-Flow Filter, Rotating Luer Lock Fitting, Color Coded End_NS_100ea/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 |
|---|---|---|---|---|
| NKC | Tubing/Tubing With Filter, Insufflation, Laparoscopic | Obstetrics/Gynecology | 884.1730 | 1 |
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 | 26931918171255 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 16931918171258 | GS1 | ||||
| Unit of Use | 06931918171251 | GS1 |
Customer Contacts
- Phone
- +86057383617385
- [email protected]