AccessGUDID - DEVICE: IMPROVACUTER® Blood Collection Set with Pre-Attached Holder (06933395621045)

GUDID

Device Identifier (DI) Information

Brand Name: IMPROVACUTER® Blood Collection Set with Pre-Attached Holder
Version or Model: 21G x 3/4” x 12”
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Guangzhou Improve Medical Instruments Co., Ltd.

Primary DI Number: 06933395621045
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 530148444 *Terms of Use

Device Description: No description.

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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
Blood collection needle	A sterile, sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood collection set for drawing blood from a patient. It is intended to be connected to blood collection tubing and/or a blood collection Luer connector for transfer into a blood specimen receptacle. It may include a pre-attached blood collection tube spike however it does not include a blood collection tube holder. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Blood collection needle

A sterile, sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood collection set for drawing blood from a patient. It is intended to be connected to blood collection tubing and/or a blood collection Luer connector for transfer into a blood specimen receptacle. It may include a pre-attached blood collection tube spike however it does not include a blood collection tube holder. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
FMI	Needle, Hypodermic, Single Lumen

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153388	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

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d0d0ec6e-c477-411b-8e4a-79d90384cae1
Public Version Date: January 08, 2019
Public Version Number: 4
DI Record Publish Date: December 23, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number	Quantity per Package	Contains DI Package	Package Status
56933395621040	4	16933395621042	In Commercial Distribution
16933395621042	50	06933395621045	In Commercial Distribution
46933395621043	10	16933395621042	In Commercial Distribution