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”
Catalog Number:
Company Name: Guangzhou Improve Medical Instruments Co., Ltd.

Primary DI Number: 06933395621045
Issuing Agency: GS1
Device Count: 1

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, basic	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. This is a single-use device.

FDA Product Code

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

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 Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: December 23, 2016
Commercial Distribution End Date:

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

Secondary DI

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

Unit of Use DI

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

Direct Marking (DM)

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

Production Identifier(s) in UDI

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

Customer Contact

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No Customer Contact currently defined

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