BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Argyle

DI: 10884527000340 · Model: 10000 · Cardinal Health, Inc.

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Product Codes

1

GMDN Terms

1

Identifiers

3

Pkg Device Count

1

Basic Information

Brand Name: Argyle
Primary DI: 10884527000340
Version / Model: 10000
Catalog Number: 10000
Company Name: Cardinal Health, Inc.
Labeler DUNS: 080935429
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2018-06-22
Public Version: 3
Public Version Date: 2019-05-23
Public Version Status: Update
Public Device Record Key: c9e8e017-3bda-40e1-be58-c1478ec212b1

Device Description

Sterile Water

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: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
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
FRO	Dressing, wound, drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
37207	Surgical/medical procedure irrigation fluid	A solution, typically saline, intended to be used to flush an anatomical site for clearing and cleaning during a surgical/medical procedure (e.g., ocular area during eye surgery, middle ear during an ENT procedure). The solution may be supplied in a prefilled syringe. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884527000347	GS1	PACK_OR_INNER_PACK	6	In Commercial Distribution
Primary	10884527000340	GS1
Package	30884527000344	GS1	CASE	48	In Commercial Distribution

Customer Contacts

Phone: +1(508)261-8000
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K083042	000

Device Sizes

Type	Value	Unit	Text
Total Volume	100	Milliliter

Storage Conditions

Type: Special Storage Condition, Specify
Special Conditions: This side up;