AccessGUDID - DEVICE: BD Vacutainer® No Additive (Z) Tubes (30382903667094)

GUDID

Device Identifier (DI) Information

Brand Name: BD Vacutainer® No Additive (Z) Tubes
Version or Model: 366709
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 366709
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 30382903667094
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 001292192 *Terms of Use

Device Description: TUBE EST PLH 13X75 2.0 PLBL PNK

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):	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?
47590	Evacuated blood collection tube IVD, no additive	A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum with no additive. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., serum chemistry determinations including trace elements, serology, and toxicology). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMH	CONTAINER, SPECIMEN, STERILE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Storage Environment Temperature: between 4 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: aa8c3f5c-bb2c-45ec-8659-5dc77e33f3c9
Public Version Date: July 09, 2024
Public Version Number: 1
DI Record Publish Date: July 01, 2024