DEVICE: Briostor™ Transfer/Freezing Bag Set (00636207314680)

Device Identifier (DI) Information

Briostor™ Transfer/Freezing Bag Set
791-12
In Commercial Distribution
791-12
Global Life Sciences Solutions USA LLC
00636207314680
GS1

1
011658242 *Terms of Use
Five Chamber Transfer/Freezing Bag Set intended to be used for cord blood processing and freezing
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
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?
47115 Umbilical cord blood collection set
A 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.
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 [?]
BK150314 0
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Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Five chamber transfer/freezing bag
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Device Record Status

d9cd9130-4928-4004-99d0-123e6881562f
February 29, 2024
5
July 20, 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
30636207314681 24 00636207314680 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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)645-6578 5164843600
QAMedical@pall.com
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