Telfa 12388AMD

GUDID 20884521154084

AMD Antimicrobial Non-adherent Dressing,0.2% Polyhexamethylene Biguanide HCI (PHMB)

Cardinal Health, Inc.

Wound-nonadherent dressing, absorbent, sterile Wound-nonadherent dressing, absorbent, sterile Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial Wound-nonadherent dressing, absorbent, non-antimicrobial

Primary Device ID	20884521154084
NIH Device Record Key	49c61c2a-c0d8-4152-8042-244a7f06a023
Commercial Distribution Status	In Commercial Distribution
Brand Name	Telfa
Version Model Number	12388AMD
Catalog Number	12388AMD
Company DUNS	080935429
Company Name	Cardinal Health, Inc.
Device Count	200
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Customer Support Contacts

Phone	+1(508)261-8000
Email	covidien.udi@covidien.com
Phone	+1(508)261-8000
Email	covidien.udi@covidien.com

Device Dimensions

Length	8 Inch
Width	3 Inch
Length	8 Inch
Width	3 Inch
Length	8 Inch
Width	3 Inch
Length	8 Inch
Width	3 Inch
Length	8 Inch
Width	3 Inch
Length	8 Inch
Width	3 Inch
Length	8 Inch
Width	3 Inch
Length	8 Inch
Width	3 Inch
Length	8 Inch
Width	3 Inch
Length	8 Inch
Width	3 Inch
Length	8 Inch
Width	3 Inch
Length	8 Inch
Width	3 Inch
Length	8 Inch
Width	3 Inch
Length	8 Inch
Width	3 Inch
Length	8 Inch
Width	3 Inch

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *This side up;
Special Storage Condition, Specify	Between 0 and 0 *This side up;
Special Storage Condition, Specify	Between 0 and 0 *This side up;
Special Storage Condition, Specify	Between 0 and 0 *This side up;
Special Storage Condition, Specify	Between 0 and 0 *This side up;
Special Storage Condition, Specify	Between 0 and 0 *This side up;
Special Storage Condition, Specify	Between 0 and 0 *This side up;
Special Storage Condition, Specify	Between 0 and 0 *This side up;
Special Storage Condition, Specify	Between 0 and 0 *This side up;
Special Storage Condition, Specify	Between 0 and 0 *This side up;
Special Storage Condition, Specify	Between 0 and 0 *This side up;
Special Storage Condition, Specify	Between 0 and 0 *This side up;
Special Storage Condition, Specify	Between 0 and 0 *This side up;
Special Storage Condition, Specify	Between 0 and 0 *This side up;
Special Storage Condition, Specify	Between 0 and 0 *This side up;

Device Identifiers

Device Issuing Agency	Device ID
GS1	20884521154084 [Package] Contains: 30884521154081 Package: CASE [4000 Units] In Commercial Distribution
GS1	30884521154081 [Primary]
GS1	40884521154088 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K011941

FDA Product Code

EFQ	GAUZE/SPONGE, INTERNAL

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2019-02-15
Device Publish Date	2018-06-29

On-Brand Devices [Telfa]

00884521068141	Adhesive Island Dressing
00884521065454	Adhesive Island Dressing
00884521027001	AMD Antimicrobial Non-adherent Island Dressing,0.2% Polyhexamethylene Biguanide HCI (PHMB)
00884521026981	AMD Antimicrobial Non-adherent Island Dressing,0.2% Polyhexamethylene Biguanide HCI (PHMB)
00884521026950	AMD Antimicrobial Non-adherent Island Dressing,0.2% Polyhexamethylene Biguanide HCI (PHMB)
00884521026929	AMD Antimicrobial Non-adherent Island Dressing,0.2% Polyhexamethylene Biguanide HCI (PHMB)
00884521026882	AMD Antimicrobial Non-adherent Pad,0.2% Polyhexamethylene Biguanide HCI (PHMB)
00884521026868	AMD Antimicrobial Non-adherent Pad,0.2% Polyhexamethylene Biguanide HCI (PHMB)
20884521154084	AMD Antimicrobial Non-adherent Dressing,0.2% Polyhexamethylene Biguanide HCI (PHMB)
10884521065253	Non-adherent Clear Wound Dressing
10884521532571	Non-adherent Clear Wound Dressing
10884521532564	Non-adherent Clear Wound Dressing
30884521065233	Non-adherent Clear Wound Dressing
10884521105669	Non-adherent Dressing
20884527022509	Clear Wound Dressing
30884521065356	Plus Barrier Island Dressing
40884521065346	Plus Barrier Island Dressing
30884521065332	Plus Barrier Island Dressing
30884521065325	Plus Barrier Island Dressing
20884521083216	Non-adherent Absorbent Dressing
20884527022516	Non-adherent Dressing
20884527022523	Non-adherent Dressing
20884527022547	Adhesive Dressing
20884527022530	Adhesive Dressing
20884527021922	Adhesive Island Dressing
20192253047377	Telfa Adhesive Island Dressing
20884521083254	Non-adherent Absorbent Dressing
20884521083247	Non-adherent Absorbent Dressing
30884521083190	Non-adherent Absorbent Dressing
30884521065301	Non-adherent Pad Prepack
20884521065267	Non-adherent Pad
20884521065229	Non-adherent Pads Prepack

Trademark Results [Telfa]

Mark Image Registration \| Serial	Company Trademark Application Date
TELFA 71669616 0607346 Live/Registered	KENDALL COMPANY, THE 1954-07-08