AccessGUDID - DEVICE: IV Plus® (10892855000406)

GUDID

Device Identifier (DI) Information

Brand Name: IV Plus®
Version or Model: N0657
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NEXUS MEDICAL, LLC

Primary DI Number: 10892855000406
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 169260325 *Terms of Use

Device Description: Blunt Cannula in Blister Packs

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44036	Intravascular catheter adaptor	A connecting device, usually a small part, intended to be used to join an applied catheter to an external device(s) used in the intravenous administration of fluids to a patient. This device will typically be used when the devices to be connected are from different manufacturers and are non-compatible, enabling them to mate together. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FPA	Set, Administration, Intravascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K081123	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b60ea494-4106-4439-ad56-885850bac059
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: September 12, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
30892855000400	100	10892855000406		In Commercial Distribution

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1866-336-3987
Email: TKOCUSTSERV@NEXUSMEDICAL.COM

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