AccessGUDID - DEVICE: IMPROSAFE® Blood Collection Set (06974481831009)

GUDID

Device Identifier (DI) Information

Brand Name: IMPROSAFE® Blood Collection Set
Version or Model: 25G x 3/4” x 7”
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Guangzhou Improve Medical Instruments Co., Ltd.

Primary DI Number: 06974481831009
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 554555378 *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":	Yes
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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35209	Non-fixed blood collection needle	A 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 does not include wings for fixation/placement (i.e., not a venous butterfly/scalp vein needle). 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 and/or a safety cover; however, it does not include blood collection tubing or a tube holder (i.e., not a set). This is a single-use device.	Active	false

FDA Product Code

[?]

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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 83de0aeb-96ca-441b-a729-034be098c852
Public Version Date: February 28, 2022
Public Version Number: 1
DI Record Publish Date: February 20, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status
16974481831006	50	06974481831009	In Commercial Distribution
26974481831003	100	06974481831009	In Commercial Distribution
86974481831005	20	26974481831003	In Commercial Distribution
46974481831007	20	16974481831006	In Commercial Distribution
56974481831004	10	16974481831006	In Commercial Distribution
66974481831001	4	16974481831006	In Commercial Distribution
76974481831008	12	16974481831006	In Commercial Distribution
96974481831002	4	66974481831001	In Commercial Distribution