AccessGUDID - DEVICE: UNOLOK (08903347003241)

GUDID

Device Identifier (DI) Information

Brand Name: UNOLOK
Version or Model: 19 G X ¾"
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00324
Company Name: HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED

Primary DI Number: 08903347003241
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 862318107 *Terms of Use

Device Description: UNOLOK Luer Lock Infusion Set,19 G X ¾" ( 1.10X19MM) 12" TUBE MYCO RE-ORDER # 7001-19

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?
58490	Venous butterfly needle/set	An invasive, hollow, tubular, metal device intended to puncture a vein to collect blood and/or for transient (<24 hours) or short-term (<= 30 days) administration of intravenous (IV) fluids. It includes wings for fixation/placement and may include tubing and/or connectors; however, it does not include accessories to facilitate introduction (e.g., stylet). The device may also be referred to as butterfly needle or scalp vein needle. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FOZ	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K953252	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: 59ee0172-7cff-479c-9497-004fc7f13c0c
Public Version Date: July 23, 2020
Public Version Number: 5
DI Record Publish Date: April 26, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
18903347003248	100	08903347003241	In Commercial Distribution	BOX
28903347003245	10	18903347003248	In Commercial Distribution	CARTON
58903347003246	18	28903347003245	In Commercial Distribution	PALLET