AccessGUDID - DEVICE: BD Vacutainer® K2 EDTA (K2E) 7.2mg Blood Collection Tubes (30382903678618)

GUDID

Device Identifier (DI) Information

Brand Name: BD Vacutainer® K2 EDTA (K2E) 7.2mg Blood Collection Tubes
Version or Model: 367861
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 367861
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 30382903678618
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 001292192 *Terms of Use

Device Description: TUBE K2EDTA PLH 13X75 4.0 PLBL LAV

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?
47592	Evacuated blood collection tube IVD, anticoagulant	A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and an anticoagulant [e.g., sodium heparin, sodium citrate, potassium oxalate, ethylenediaminetetraacetic acid (EDTA)]. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., blood lead, toxicology, nutritional-chemistry, and other plasma chemistry determinations). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JKA	Tubes, vials, systems, serum separators, blood collection
GIM	Tubes, vacuum sample, with anticoagulant

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK230980	000
K213670	000
K231373	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
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: e04ca23c-3d81-4566-ad7b-1e8ef5023487
Public Version Date: May 02, 2024
Public Version Number: 7
DI Record Publish Date: July 28, 2016