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
46102 Surgical irrigation tubing set, single-use

Identifiers

Type ID
Package 25060120950691
Primary 15060120950694
Package 35060120950698