Newborn Stemcell Collection Kit

Primary DI
00812589020399
Brand
Newborn Stemcell Collection Kit
Company
VIACORD, LLC
Model
ViaCord SibCon Twin Kit
Catalog number
Kit-92
Published
2019-04-10
Public version status
Update
Distribution status
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
00812589020399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812589020399008125890203998125890203990812589020399

GMDN Terms#

Term, Definition table
TermDefinition
Umbilical cord blood collection setA group of devices intended to be used to collect, process, and store umbilical cord blood and/or umbilical cord blood components (e.g., buffy coat). It typically includes tubing, hollow needles for insertion into the umbilical cord (a double venipuncture of the cord) to collect the blood, and several containers (flexible bags usually containing an anticoagulant) intended for transitional (room temperature) or long-term (frozen) blood storage. The cord blood is usually intended to be frozen and stored, typically to preserve stem cells, for subsequent reinfusion into patients, generally in cases of leukaemia. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
883775553
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812589020351Newborn Stemcell Collection KitViaCord Single KitKit-812019-04-10
00812589020368Newborn Stemcell Collection KitViaCord Twin KitKit-822019-04-10
00812589020375Newborn Stemcell Collection KitViaCord Triplet KitKit-832019-04-10
00812589020382Newborn Stemcell Collection KitViaCord SibCon Single KitKit-912019-04-10
00812589020405Newborn Stemcell Collection KitViaCord SibCon Triplet KitKit-932019-04-10