AccessGUDID - DEVICE: Screw Cap Tube 101x16 RBS with saline (04038917554633)

GUDID

Device Identifier (DI) Information

Brand Name: Screw Cap Tube 101x16 RBS with saline
Version or Model: 51.540.387
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SARSTEDT, INC.

Primary DI Number: 04038917554633
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 500
Labeler D-U-N-S® Number*: 035410179 *Terms of Use

Device Description: Screw Cap Tube 101x16 mm round bottom with skirt with saline

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?
43674	Isotonic saline reagent IVD	An unbuffered isotonic saline solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PPM	General Purpose Reagent

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 424001ff-090b-4d1a-bc47-f35b8c1e8cb1
Public Version Date: December 12, 2022
Public Version Number: 1
DI Record Publish Date: December 04, 2022