DEVICE: SPS-1® (UW Solution) (00815045020322)

Device Identifier (DI) Information

SPS-1® (UW Solution)
SPS-1
In Commercial Distribution

ORGAN RECOVERY SYSTEMS, INC.
00815045020322
GS1

1
078972580 *Terms of Use
SPS-1® (UW Solution), Static Preservation Solution (2 Liter)
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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?
18004 Donor-organ/tissue/cell preservation solution
A solution intended to be used for the flushing, transport, storage and preservation of donor cells, tissues and/or organs (e.g., stem cells, skin, amniotic membrane, cardiovascular tissue, bone, tendon, kidney, liver, heart, pancreas) intended for transplantation. The solution contains a mixture of chemicals/ingredients intended to maintain cell/tissue/organ viability until implantation in the recipient; some types may be combined with blood. After application, this device cannot be reused.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KDL Set, Perfusion, Kidney, Disposable
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K091656 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

271111dc-a2c7-42f0-9552-4b2a28f7417a
December 08, 2022
4
October 16, 2017
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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
10815045020329 5 00815045020322 In Commercial Distribution Case
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Secondary DI

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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

[?]
No Customer Contact currently defined
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