FDA UDI
In Commercial Distribution
🇺🇸 United States
Insufflation Set
DI: 15060120950694
·
Model: 6421/04BPKBTU001/0001
·
GVS FILTER TECHNOLOGY UK LTD
Product Codes
0
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Insufflation Set
- Primary DI
- 15060120950694
- Version / Model
- 6421/04BPKBTU001/0001
- Company Name
- GVS FILTER TECHNOLOGY UK LTD
- Labeler DUNS
- 769934225
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-20
- Public Version
- 1
- Public Version Date
- 2026-03-02
- Public Version Status
- New
- Public Device Record Key
- b70f04e2-d792-4cb5-8d46-3d27e2944a1b
Device Description
To be used in conjunction with insufflators for intra-abdominal insufflation
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46102 | Surgical irrigation tubing set, single-use | A collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 25060120950691 | GS1 | Inner Box | 10 | In Commercial Distribution | |
| Primary | 15060120950694 | GS1 | ||||
| Package | 35060120950698 | GS1 | Oter Box | 6 | In Commercial Distribution |