FDA.reportPublic FDA data

Dermacea

Primary DI
20884527015662
Brand
Dermacea
Company
Cardinal Health, Inc.
Model
2260
Catalog number
2260
Device description
Stretch Bandage
Published
2018-06-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQMBANDAGE, ELASTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884527015662PackageGS112In Commercial Distribution
30884527015669PackageGS196In Commercial Distribution
10884527015665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452701566220884527015662
3088452701566930884527015669
1088452701566510884527015665

GMDN Terms#

Term, Definition table
TermDefinition
Pressure bandage, non-latex, single-useA strip or roll of fabric or plastic material (non-latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return). It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Width2Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00This side up;

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080935429
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521190948Kangaroo384500W384500W2017-09-12
10884521190894Kangaroo3844003844002017-08-02
10884521544475Wings67093670932018-06-27
20884521544489Wings67095670952018-06-27
10884521023284Monoject8507SA8507SA2016-09-24
10884521208742Devon31145892311458922018-06-29
20884521154244Monoject8985PG2Y8985PG2Y2017-01-06
20884521513423Kendall8618RC8618RC2017-05-27
20884521706177Kangaroo388105E388105E2017-04-20
20884527016034Devon31145926311459262018-06-29
30884521022533Monoject8997SPG28997SPG22016-09-24
30884521022557Monoject8998SPG28998SPG22016-09-24
30884527016048Devon31145942311459422018-06-29
40884521022417Monoject8932PG28932PG22016-09-24
10884521019119SharpSafety8556H8556H2018-06-27
20884527000125Argyle888825737888882573782016-09-24
20884527000132Argyle888825738688882573862016-09-24
10884527019854Argyle888850103188885010312016-09-24
10884527019922Argyle888850200588885020052016-09-24
10884527019847Argyle888850102388885010232016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07333350030384Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350102111Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350354831Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350472917Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350589110Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350644635Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350721589Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350753856Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350758288Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350929640Tubigrip®Mölnlycke Health Care ABFQM2026-09-21
07333350094850Tubigrip®Mölnlycke Health Care ABFQM2026-09-18
07333350874889Tubigrip®Mölnlycke Health Care ABFQM2026-09-18
00850087488808CeeportCEEPORT INC.FQM2026-08-26
00850087488815CeeportCEEPORT INC.FQM2026-08-26
00850087488822CeeportCEEPORT INC.FQM2026-08-26
00850087488839CeeportCEEPORT INC.FQM2026-08-26
00050428124505CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFQM2026-08-14
00850088144024CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144031CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144048CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144055CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144062CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144079CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144086CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-14
00850088144666CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-10
00850088144673CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-10
00850088144680CARBOUNingbo kehu Medical Technology Co.,Ltd.FQM2026-07-10
00850087488273CeeportCEEPORT INC.FQM2026-06-08
06978479041074LotfancyAnhui Medsport Medical Products Co., Ltd.FQM2026-06-03
08809302580645New Soosung Elastic Bandagesoosung medicalFQM2025-12-26