AccessGUDID - DEVICE: AMSure® IV Start Kit (10704411017837)

GUDID

Device Identifier (DI) Information

Brand Name: AMSure® IV Start Kit
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IVSK005
Company Name: AMSINO INTERNATIONAL, INC.

Primary DI Number: 10704411017837
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 825673239 *Terms of Use

Device Description: 1 Pre-Filled Normal Saline Flush Syringe 10 cc(sterilized)(China) 1 Extension set(sterilized)(China) 1 Alcohol prep pad(sterilized)(China) 1 Patient label(Non-sterile)(China) 1 Gauze, 2'' x 2''x2, 4 ply(sterilized)(China) 1 Mini roll of tape(Non-sterile)(China) 1 Tegaderm, 6 cm x 10 cm(sterilized)(China) 1 Tourniquet 1'' x 18'', Blue, Rolled(Non-sterile)(China)

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":	Yes
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?
64573	Peripheral intravenous catheterization kit, non-sensing	A collection of non-powered devices intended for the introduction of an included peripheral vein cannula, often referred to as a catheter, to enable short-term (= 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. In addition to the cannula, it includes non-dedicated devices intended to support the procedure [e.g., tourniquet, swabs, dressings, disinfectants (e.g., alcohol), tape, gloves]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRS	I.V. Start Kit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K050654	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9633b8ac-ac55-4567-bbda-61b9b7284f00
Public Version Date: July 01, 2025
Public Version Number: 1
DI Record Publish Date: June 23, 2025