FDA UDI Not in Commercial Distribution 🇺🇸 United States

INSUFLOW SYNERGY PORT

DI: 00852588007083 · Model: 1991 · LEXION MEDICAL, LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
INSUFLOW SYNERGY PORT
Primary DI
00852588007083
Version / Model
1991
Catalog Number
1991
Company Name
LEXION MEDICAL, LLC
Labeler DUNS
848693730
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-02-15
Public Version
4
Public Version Date
2023-06-09
Public Version Status
Update
Public Device Record Key
8b9ad45d-347a-4463-8dde-ce4cb68fdcf5
Distribution End Date
2020-01-02

Device Description

5mm GAS CONDITIONING PORT

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
Yes
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
Yes
Sterilization Methods
Ethylene Oxide

Product Codes

Code Name
HIF Insufflator, Laparoscopic
GCJ Laparoscope, General & Plastic Surgery

GMDN Terms

Code Name
42412 Laparoscopic access cannula, single-use

Identifiers

Type ID
Primary 00852588007083