AccessGUDID - DEVICE: Vacuette (29120017574013)

GUDID

Device Identifier (DI) Information

Brand Name: Vacuette
Version or Model: 454081
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 454081
Company Name: Greiner Bio-One GmbH

Primary DI Number: 29120017574013
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 303639066 *Terms of Use

Device Description: VACUETTE® TUBE 1 ml LH Lithium Heparin 13x75 green cap-white ring, PREMIUM

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?
47589	Evacuated blood collection tube IVD, lithium heparin	A sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and the anticoagulant lithium heparin. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., plasma chemistry determinations). This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JKA	Tubes, vials, systems, serum separators, blood collection

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K960857	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: c0c68378-89c1-447d-bcbe-064a418cadac
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
39120017574010	24	29120017574013		In Commercial Distribution

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 19120017574016 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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