DEVICE: Typesafe 2.0 (10812269031230)
Device Identifier (DI) Information
Typesafe 2.0
SP0201QD
In Commercial Distribution
TYPENEX MEDICAL LLC
SP0201QD
In Commercial Distribution
TYPENEX MEDICAL LLC
Typesafe 2.0 - Quantity 500
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
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? |
---|---|---|---|---|
60210 | Blood donor bag segment sampling IVD |
A sampling device intended to be used for extracting a blood specimen from a blood donor bag tubing segment for analysis and/or other investigation (e.g., blood grouping, cross matching). It typically consists of a needle surrounded by plastic housing designed so that the blood-filled tubing segment may be inserted into the housing, pierced by the needle, and a sample manually extracted without exposing the user to either the blood or the needle. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KSS | Supplies, Blood-Bank |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
BK150351 | 0 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
59a40e29-fc2e-4afd-b6c2-8dd5cb619d2b
November 29, 2022
1
November 21, 2022
November 29, 2022
1
November 21, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
00812269031240 | 1 | 10812269031230 | In Commercial Distribution | Carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00812269031233
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined