DEVICE: COBE Spectra DN ELP Set (05020583711006)

Device Identifier (DI) Information

COBE Spectra DN ELP Set
71100
In Commercial Distribution

TERUMO BCT, INC.
05020583711006
GS1

1
801679200 *Terms of Use
COBE Spectra DN ELP Set
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Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

[?]
Product Code Product Code Name
GKT Separator, automated, blood cell, diagnostic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
BK950065 0
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 0 and 35 Degrees Celsius
Special Storage Condition, Specify: Protect from rain
Special Storage Condition, Specify: Keep out of sunlight.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

b4328679-b68a-4af7-be72-3cd8f8f4c5af
July 06, 2018
3
September 15, 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
No Package DIs found
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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

[?]
+1(303)205-2510
FDAUDIprogram@terumobct.com
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