DEVICE: TUBING ORGANIZER - NON-STERILE (B066311033NS1)

Device Identifier (DI) Information

TUBING ORGANIZER - NON-STERILE
311033NS
In Commercial Distribution
311033NS
NOVOSCI CORP.
B066311033NS1
HIBCC

200
938289980 *Terms of Use
A small, non-sterile device with a locking/holding mechanism designed to secure most any kind of tubing or tubing-like device (e.g., cables, cords) to a patient or to a surgical drape during a clinical intervention. It is typically designed as: 1) an adhesive pad (plaster), strip, or bandage intended to attach to the patient's skin or drape with the exposed side (top side) having an integrated fixation mechanism (e.g., Velcro hook/loop closure); or 2) a mechanical closure or gripping system intended to hold the tubing or tubing hub in place. This device is not designed to hold a specific type or brand of tubing. This is a single-use device intended to be sterilized prior to use.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
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
Universal patient tubing holder, non-sterile A small, non-sterile device with a locking/holding mechanism designed to secure most any kind of tubing or tubing-like device (e.g., cables, cords) to a patient or to a surgical drape during a clinical intervention. It is typically designed as: 1) an adhesive pad (plaster), strip, or bandage intended to attach to the patient's skin or drape with the exposed side (top side) having an integrated fixation mechanism (e.g., Velcro hook/loop closure); or 2) a mechanical closure or gripping system intended to hold the tubing or tubing hub in place. This device is not designed to hold a specific type or brand of tubing. This is a single-use device intended to be sterilized prior to use.
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FDA Product Code

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Product Code Product Code Name
KRI Accessory Equipment, 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

c6f4e25c-8d70-4899-8c71-439046e2660e
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
B066311033NS3 100 B066311033NS1 In Commercial Distribution INNER BAG
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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: B066311033NS 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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