FDA UDI In Commercial Distribution 🇺🇸 United States

Infusion Pump Tube Set with Dampening Chamber

DI: 00627825000451 · Model: IPTS-DC-LT2 · Laborie Medical Technologies Canada ULC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Infusion Pump Tube Set with Dampening Chamber
Primary DI
00627825000451
Version / Model
IPTS-DC-LT2
Company Name
Laborie Medical Technologies Canada ULC
Labeler DUNS
203383526
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-21
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
2fdd6989-bd7e-4f7d-9735-9242b6ca93f8

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
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
FEN DEVICE, CYSTOMETRIC, HYDRAULIC

GMDN Terms

Code Name
35833 Electric infusion pump administration set, single-use

Identifiers

Type ID
Package 10627825000458
Primary 00627825000451