DEVICE: XTRA (08033178114332)

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Device Record History
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Device Identifier (DI) Information
XTRA
SEQUESTRATION SET X
In Commercial Distribution

SORIN GROUP ITALIA SRL
08033178114332
GS1

1
442126587 *Terms of Use
No description.
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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?
44034 Blood donor set, double-pack
An assembly of sterile devices intended to be used to collect whole blood from a donor and separate the red blood cells and plasma. It includes two containers (flexible bags) ? one with anticoagulation solution and/or preservatives for red blood cells, tubing, and an attached needle for venipuncture. It may include integrated features such as an in-line leukocyte filter, pre-donation blood sampling device, and/or needle stick prevention device. After collection, the red blood cells and plasma are separated, via centrifugation, into separate containers and subsequently tested, stored, and infused from the containers when needed. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CAC Apparatus, autotransfusion
DTN Reservoir, blood, cardiopulmonary bypass
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K241236 000
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
10a7a2d8-a7df-474f-aebb-e826ca1d6a06
December 30, 2024
1
December 20, 2024
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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
38033178114333 40 18033178114339 In Commercial Distribution BOX
18033178114339 8 08033178114332 In Commercial Distribution BOX
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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

[?]
No Customer Contact currently defined
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