DEVICE: QC Bagset (00886368000322)

Device Identifier (DI) Information

QC Bagset
70176
In Commercial Distribution
8-5110
Thermogenesis Corp.
00886368000322
GS1

1
080690327 *Terms of Use
Utilized for quality control testing of the AXP Device.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
16534 Cryobiological storage container
A super-insulated vessel designed to store cryobiological specimens (frozen tissues/organs), typically with the use of liquid nitrogen (LN2), for an indefinite period. The device is typically designed to store multiple specimens.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OAO Cord Blood Processing System And Storage Container
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
BK070006 0
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: 15 deg C to 30 deg C, Keep dry
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

7cb61118-52a3-4fbb-ac1b-ea365af6ad77
January 12, 2021
5
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20886368000326 4 10886368000329 In Commercial Distribution Pallet
10886368000329 10 00886368000322 In Commercial Distribution Case
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
916-858-5100
customerservice@cescatherapeutics.com
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