NA

Basic Information

• Brand Name: NA
• Primary DI: 00085412624822
• Version / Model: ADS201815
• Catalog Number: ADS201815
• Company Name: BAXTER HEALTHCARE CORPORATION
• Labeler DUNS: 005083209
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-03
• Public Version: 6
• Public Version Date: 2022-11-03
• Public Version Status: Update
• Public Device Record Key: 0c49ac77-9660-4db1-9f34-44abdfcdd88d

Device Description

DISPOSABLE CURVED APPLICATOR

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KYZ	SYRINGE, IRRIGATING (NON DENTAL)	General Hospital	880.6960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47186	Haematological concentrate/haemostatic agent applicator	A hand-held, manually-operated device designed to administer, in a liquid or spray form, a haematological concentrate and/or haemostatic agent (e.g., thrombin, platelet concentrate, plant polysaccharide) to a surgical wound, lesion, or graft during surgery (open and/or endoscopic), typically to facilitate haemostasis and healing. It is typically a syringe-/plunger-like, single-channel or dual-channel (for co-administration of two separate agents) device, which may also be designed for connection to a gas pump for spraying. Delivery cannula(s)/tip(s) may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20085412624826	GS1	PACK_OR_INNER_PACK	10	In Commercial Distribution
Primary	00085412624822	GS1
Package	50085412624827	GS1	CA	24	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			10 Centimeter x 10 Gauge

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store between 2 degrees Celsius to 25 degrees Celsius, 36 degrees Fahrenheit to 77 degrees Fahrenheit. Store in original packaging. Keep away from sunlight and excessive heat.