AccessGUDID - DEVICE: ONE-CARE Safety Blood Collection Needles (00810008212899)

GUDID

Device Identifier (DI) Information

Brand Name: ONE-CARE Safety Blood Collection Needles
Version or Model: 5020-H ONE-CARE Safety Blood Collection Needles 22G x 1 1/4'' with Holders
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5020-H
Company Name: MediVena, LLC

Primary DI Number: 00810008212899
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080740980 *Terms of Use

Device Description: ONE-CARE Safety Blood Collection Needles 22G x 1 1/4'' with Holders, Black, 100/bx, 5bx/cs

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?
58284	Blood collection tube holder/needle	A sterile, hand-held cylindrical device with a pre-attached needle designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor with a pre-attached blood collection needle at one end and into which the blood collection tube is inserted at the other end; this also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172763	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
Handling Environment Temperature: between 32 and 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 22 Gauge
Length: 1.25 Inch

Device Record Status

Public Device Record Key: 6fe3aea4-c3c3-47aa-9e65-ffabecc444e4
Public Version Date: October 07, 2024
Public Version Number: 1
DI Record Publish Date: September 27, 2024