FDA UDI In Commercial Distribution 🇺🇸 United States

Resp-O2 Oxygen CO2 Sampling Line

DI: 00840117316164 · Model: 33086 · DYNAREX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Resp-O2 Oxygen CO2 Sampling Line
Primary DI
00840117316164
Version / Model
33086
Company Name
DYNAREX CORPORATION
Labeler DUNS
008124539
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-04-22
Public Version
1
Public Version Date
2021-04-30
Public Version Status
New
Public Device Record Key
d2a572e4-bf93-48ef-aea4-e6ff81a8b6ac

Device Description

Resp-O2 Oxygen CO2 7' (2.1m) Sampling Line with Filter, male/female connector

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
MR Safe
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

GMDN Terms

Code Name
62698 Capnography sampling adaptor

Identifiers

Type ID
Package 00840117316089
Primary 00840117316164

Premarket Submissions

Submission Number Supplement Number
K143150 000