IQLung (PR) 55

GUDID G29255090

Specimen Collection Kit

Biodesix, Inc.

Blood collection set, invasive
Primary Device IDG29255090
NIH Device Record Keyf32476df-9d3d-4f27-8d3e-501862bfbe82
Commercial Distribution Discontinuation2026-02-03
Commercial Distribution StatusNot in Commercial Distribution
Brand NameIQLung (PR)
Version Model Number9
Catalog Number55
Company DUNS809047215
Company NameBiodesix, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCG29255080 [Previous]
HIBCCG29255090 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-11
Device Publish Date2026-02-03

On-Brand Devices [IQLung (PR)]

G292550Sample Collection Kit
G29255080Sample Collection Kit
G29255090Specimen Collection Kit

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