FDA.reportPublic FDA data

Nodify

Primary DI
G29251120
Brand
Nodify
Company
Biodesix, Inc.
Model
12
Catalog number
51
Device description
Specimen Collection Kit
Published
2026-02-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G29251110PreviousHIBCC0
G29251120PrimaryHIBCC0

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 Temperature00

Regulatory Flags#

DUNS number
809047215
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G29251130Nodify13512026-10-22
G29256100Nodify (PR)10562026-10-22
G29256090Nodify (PR)9562026-02-10
G29259070Capillary Blood Specimen Collection Supplemental Pack7592025-08-28
G29251110Nodify11512025-05-07
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