AccessGUDID - DEVICE: Capillary Caps (00630414115764)

GUDID

Device Identifier (DI) Information

Brand Name: Capillary Caps
Version or Model: 10311053
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 478601
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414115764
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: 200 capillary caps. An in vitro diagnostics medical device for use with Siemens Healthcare Diagnostics. 1.65mm OD Glass blood collection capillary tubes.

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?
61419	Capillary blood collection tube IVD, electrolyte-balanced heparin	A non-sterile glass or plastic collection tube containing electrolyte-balanced heparin (anticoagulant), intended to be used for the collection, preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit, neonatal bilirubin, plasma chemistry determinations). 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9055ab64-2354-4a4e-a76b-8797609b7043
Public Version Date: January 19, 2022
Public Version Number: 4
DI Record Publish Date: September 24, 2016