DEVICE: N/A (00817827021091)

Device Identifier (DI) Information

N/A
03-220-BC12
In Commercial Distribution
03-220-BC12
CHARTER MEDICAL, LTD.
00817827021091
GS1

1
029062325 *Terms of Use
Plasma/Fluid Transfer Set 12mL Monoject™ Syringe and Adapter Cap Assembly
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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?
44903 Blood transfer set
A collection of sterile, flexible, plastic tubing and associated items (e.g., couplers, adapters, clamps) used to transfer blood or blood components (e.g., peripheral stem cells, plasma) into containers or between containers for processing or storage (e.g., freezing). This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KSB Set, Transfer (Blood/Plasma)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
BK050021 0
No CLOSE

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
No Device Sizes
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Device Record Status

d20e7b15-975a-45b6-96e8-e46fa81e61ea
July 06, 2018
3
September 24, 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
00817827021596 96 00817827021091 In Commercial Distribution
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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
Yes
No CLOSE

Customer Contact

[?]
(866) 458-3116
CML_CustomerService@CharterMedical.com
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