FDA.reportPublic FDA data

Monarch 25G BCS

Primary DI
20850058273093
Brand
Monarch 25G BCS
Company
THE MONARCH CO., LLC
Model
M2512H
Device description
"Safety Blood Collection Set 25g, 3/4"" Needle, 12"" tubing, with luer Slip holder"
Published
2024-01-11
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232308000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232308000Monarch Blood Collection SetThe Monarch Company2023-12-04JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850058273093PrimaryGS10
00850058273099Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085005827309320850058273093
00850058273099008500582730998500582730990850058273099

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.

Regulatory Flags#

DUNS number
119086771
Device count
100
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850058273034Monarch 21G BCSM2112L2024-01-17
10850058273065Monarch 25G BCSM2512L2024-01-17
20850058273031Monarch 21G BCSM2112L2024-01-17
20850058273062Monarch 25G BCSM2512L2024-01-17
00850058273037Monarch 21G BCSM2112L2024-01-17
00850058273068Monarch 25G BCSM2512L2024-01-17
10850058273058Monarch 23G BCSM2312L2024-01-11
10850058273089Monarch 23G BCSM2312H2024-01-11
10850058273096Monarch 25G BCSM2512H2024-01-11
10850058273133Monarch 21G BCSM2112HLL2024-01-11
10850058273140Monarch 23G BCSM2306HLL2024-01-11
10850058273157Monarch 23G BCSM2312HLL2024-01-11
10850058273164Monarch 25G BCSM2512HLL2024-01-11
20850058273055Monarch 23G BCSM2312L2024-01-11
20850058273086Monarch 23G BCSM2312H2024-01-11
20850058273130Monarch 21G BCSM2112HLL2024-01-11
20850058273147Monarch 23G BCSM2306HLL2024-01-11
20850058273154Monarch 23G BCSM2312HLL2024-01-11
20850058273161Monarch 25G BCSM2512HLL2024-01-11
30850058273076Monarch 21G BCSM2112H2024-01-11

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