FDA.reportPublic FDA data

PIVO 24G

Primary DI
00850984007089
Brand
PIVO 24G
Company
VELANO VASCULAR, INC.
Model
202-0011
Catalog number
202-0011
Device description
24G Compatible PIVO Blood draw device
Published
2019-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850984007086PackageGS150In Commercial Distribution
00850984007089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085098400708610850984007086
00850984007089008509840070898509840070890850984007089

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection tube holder, single-useA hand-held cylindrical device designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor into which the blood collection tube is inserted and to which the user attaches a hypodermic blood collection needle (not included); it may include an integrated blood collection tube spike. This device also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge24Gauge

Regulatory Flags#

DUNS number
079714011
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850984007003PIVO 20G000-0010000-00102017-01-03
00850984007010PIVO 22G000-00112017-01-03
10850984007086PIVO 24G202-0011202-00112019-12-16
00850984007027PIVO 20G202-00052017-07-11
00850984007034PIVO 22G202-00062017-07-11
10850984007000PIVO 20G000-0010000-00102017-01-03
10850984007017PIVO 22G000-00112017-01-03

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