FDA.report

McKesson

Primary DI
20612479259632
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
MS9212NF
Device description
IV Set
Published
2021-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FPASet, Administration, Intravascular

Product Code Classifications

CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20612479259632PackageGS150In Commercial Distribution
40612479259643PackageGS16In Commercial Distribution
10612479259628PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2061247925963220612479259632
4061247925964340612479259643
1061247925962810612479259628

GMDN Terms

TermDefinition
Blood transfusion set, non-exchangeAn intravascular administration set intended to be used to administer blood from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device typically includes a needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, a stopcock, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an intravenous (IV) bag or other infusion fluid container. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
023904428
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00612479124455McKesson16-71322026-03-11
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00612479185388McKesson70-1121MCK2026-03-11
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40612479280920McKesson16-1000-PMBL2026-02-26
40612479262162McKesson18-3300M2026-02-23
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10612479281582McKesson181-342252026-02-06
00612479278356McKesson16-61442026-01-26
00612479278370McKesson16-61482026-01-26
00612479278387McKesson16-61682026-01-26
00612479278431McKesson16-618102026-01-26

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