AccessGUDID - DEVICE: SampLok® System with Hinged Lid (19555240401158)

GUDID

Device Identifier (DI) Information

Brand Name: SampLok® System with Hinged Lid
Version or Model: A100645
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A100645
Company Name: ITL ASIA PACIFIC SDN. BHD.

Primary DI Number: 19555240401158
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 597723837 *Terms of Use

Device Description: SampLok® System with Hinged Lid (Wider Bore), Clear Assembled with PP Luer, Individual Packaged Sterile; Intended to be used as a part of vacuum blood collection equipment for the collection of blood samples for various types of blood tests

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?
58284	Blood collection tube holder/needle	A sterile, hand-held cylindrical device with a pre-attached needle designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor with a pre-attached blood collection needle at one end and into which the blood collection tube is inserted at the other end; this also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection
FMI	Needle, Hypodermic, Single Lumen

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K021941	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
Special Storage Condition, Specify: Keep Dry
Special Storage Condition, Specify: Keep Away From Direct Sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b1c619af-4e42-46bc-98be-716284af33cc
Public Version Date: April 08, 2019
Public Version Number: 1
DI Record Publish Date: March 29, 2019