AccessGUDID - DEVICE: RNA Medical (10851290002550)

GUDID

Device Identifier (DI) Information

Brand Name: RNA Medical
Version or Model: CVC 123
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CVC 123
Company Name: Rna Medical Division

Primary DI Number: 10851290002550
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 101187037 *Terms of Use

Device Description: Carton for CVC 123

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:	Yes
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?
42722	Flow cytometer calibration/verification solution IVD	A solution containing beads or particles with known optical and physical characteristics (e.g., antibodies conjugated with fluorescent dyes, specified size or other label) intended to be used to verify and/or optimize the performance of a flow cytometer or similar single/multichannel instrument. Verification/optimization functions may include optical density (absorbance), fluorescent or luminescent accuracy and compensation, linearity, repeatability, sensitivity, limit of detection and/or light scatter readings at specified wavelengths, and the ability to verify optical alignment and precision of the instrument or analyser. Solutions are typically single-use.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JJY	Multi-Analyte Controls, All Kinds (Assayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K943754	000

Device Exempt from Premarket Submission: No 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: ad9dbc8c-1a4e-46f0-99db-cb90138cbc71
Public Version Date: August 19, 2020
Public Version Number: 1
DI Record Publish Date: August 11, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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