AccessGUDID - DEVICE: SampLok® Adapter Cap 3 Insert (09555240401557)

GUDID

Device Identifier (DI) Information

Brand Name: SampLok® Adapter Cap 3 Insert
Version or Model: A100763
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: A100763
Company Name: ITL ASIA PACIFIC SDN. BHD.

Primary DI Number: 09555240401557
Issuing Agency: GS1
Commercial Distribution End Date: November 11, 2024
Device Count: 1000
Labeler D-U-N-S® Number*: 597723837 *Terms of Use

Device Description: SampLok® Adaptor Cap 3 (SAC 3) Insert is an optional accessory to be used with SAC 3 to facilitate collection of blood sample into vacuum tube(s). It is a single use device.

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?
37566	Blood collection tube holder, single-use	A hand-held cylindrical device 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 into which the blood collection tube is inserted and to which the user attaches a hypodermic blood collection needle (not included); it may include an integrated blood collection tube spike. This device 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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K000777	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
Special Storage Condition, Specify: Keep Away From Direct Sunlight
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 596fd7a5-cc8a-4330-878d-46f3b1c0a07b
Public Version Date: November 12, 2024
Public Version Number: 3
DI Record Publish Date: March 29, 2019