FDA.reportPublic FDA data

Nodify

Primary DI
G29251110
Brand
Nodify
Company
Biodesix, Inc.
Model
11
Catalog number
51
Device description
Sample Collection Kit
Published
2025-05-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G29251110PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection set, invasiveA collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
809047215
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G29251130Nodify13512026-10-22
G29256100Nodify (PR)10562026-10-22
G29251120Nodify12512026-02-10
G29256090Nodify (PR)9562026-02-10
G29259070Capillary Blood Specimen Collection Supplemental Pack7592025-08-28
G29252130IQLung13522025-05-06
G29259080Capillary Blood Specimen Collection Supplemental Pack8592026-02-10
G29252150IQLung15522026-02-10
G29255100IQLung (PR)10552026-02-10
G29252140IQLung14522026-02-03
G29255090IQLung (PR)9552026-02-03
G29256080Nodify (PR)8562025-05-07
G29255080IQLung (PR)8552025-05-06
G292590Capillary Blood Specimen Collection Supplemental Pack 6592023-07-27
G292560Nodify Lung (PR)7562023-03-08
G292550IQLung (PR)7552023-03-08
G292520IQLung12522023-03-08
G292570Hibercell PAN21111572023-03-08
G292510Nodify Lung10512023-03-08