AccessGUDID - DEVICE: RAPIDPoint ® 340/350 Capillary Tubes 100ul (00630414566283)

GUDID

Device Identifier (DI) Information

Brand Name: RAPIDPoint ® 340/350 Capillary Tubes 100ul
Version or Model: 10375804
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10375804
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414566283
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Capillary Tube Kit, for use with RapidPoint® 340/350 analyzers; contents: 2 vials (100 each) capillary tubes, 1 bag (500) end caps

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61388	Capillary blood collection tube IVD, lithium heparin	A non-sterile glass or plastic collection tube containing the anticoagulant lithium heparin, intended to be used for the collection, preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit, neonatal bilirubin). It is typically sealed at one or both ends with a putty-like substance following specimen collection. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GIO	TUBE, COLLECTION, CAPILLARY BLOOD

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 18 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 758bae21-8e5f-42b7-9cf6-ae8a4fabbf9f
Public Version Date: November 19, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016