DEVICE: SPIKE, BLOOD W/ 1/4" CONN COVER (B066301103NS1)

Device Identifier (DI) Information

SPIKE, BLOOD W/ 1/4" CONN COVER
301103NS
In Commercial Distribution
301103NS
NOVOSCI CORP.
B066301103NS1
HIBCC

250
938289980 *Terms of Use
A small, sterile device intended to connect an intravenous (IV) fluid bag or blood bag to a fluid line to administer fluid to a patient. It consists of a plastic hollow spike at one end intended to be inserted into the IV bag port, a connector at the other end to attach to the IV line (typically via a drip chamber) and may include an additional administration port (i.e., Y-site device). It does not include a built-in drip chamber. This is a single-use device.
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Intravenous fluid bag spike A small, sterile device intended to connect an intravenous (IV) fluid bag or blood bag to a fluid line to administer fluid to a patient. It consists of a plastic hollow spike at one end intended to be inserted into the IV bag port, a connector at the other end to attach to the IV line (typically via a drip chamber) and may include an additional administration port (i.e., Y-site device). It does not include a built-in drip chamber. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

e8ee293c-e1e6-40cf-b729-817bef589439
March 29, 2018
2
October 13, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
B066301103NS5 1000 B066301103NS1 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

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Unit of Use DI Number: B066301103NS0 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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