FDA.report

McKesson

Primary DI
00612479240490
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
555
Device description
Micro-Hematocrit Capillary Tubes
Published
2020-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
GIOTube, Collection, Capillary Blood

Product Code Classifications

CodeDeviceSpecialtyClass
GIOTube, Collection, Capillary BloodHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00612479203693PrimaryGS10
00612479240490Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479203693006124792036936124792036930612479203693
00612479240490006124792404906124792404900612479240490

GMDN Terms

TermDefinition
Capillary blood collection tube IVD, ammonium heparinA non-sterile glass or plastic collection tube containing the anticoagulant ammonium heparin, intended to be used for the collection preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit, neonatal bilirubin). It is typically sealed at one or both ends with a putty-like substance following specimen collection. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
023904428
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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