FDA.reportPublic FDA data

V. Mueller

Primary DI
20885403206440
Brand
V. Mueller
Company
CAREFUSION 2200, INC
Model
014.03
Catalog number
014.03
Device description
ESMARK BANDAGE ESMARK BANDAGE 6" X 12'
Published
2018-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
20885403206440PrimaryGS10
10885403206443Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088540320644020885403206440
1088540320644310885403206443

GMDN Terms#

Term, Definition table
TermDefinition
Pressure bandage, non-latex, sterileA sterile strip or roll of fabric or plastic material (non-latex) intended to be applied to and compress a local area of the body for various preventative/therapeutic applications (e.g., to stop bleeding, prevent oedema, provide support for varicose veins). It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088Customer_Support@BD.com
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
832696038
Device count
15
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50382909101206Surgiphor9101209101202026-03-05
10885403273780PleurX50-007550-00752017-06-12
10885403075964PleurX50-905050-90502017-06-12
50885403075993Denver42-200042-20002017-06-12
50885403076006Denver42-205542-20552017-06-12
50885403076082Denver42-205042-20502017-06-12
10885403051722V. MuellerHY21305HY213052017-08-11
10885403049408V. MuellerGU4050-008GU4050-0082018-08-30
10885403071263V. MuellerNL1350NL13502018-09-05
10885403105159V. MuellerOS5000-002OS5000-0022018-09-10
20885403473170N/A5513E5513E2019-03-25
50885403142176Wet Exidine448944892018-07-18
50885403142183NA442044202018-07-18
50885403142190NA4461A4461A2018-07-18
50885403142220NA4472A4472A2018-07-18
50885403175211NA443744372018-07-18
50885403184473NA446844682018-07-18
50885403184480NA4469A4469A2018-07-18
50885403192829Scrub Care ExidineCLEAN1CLEAN12018-05-02
10885403465154Snowden-PencerSI325SI3252018-01-16

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Primary DI, Brand, Company table
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00810178884605ViveCareVIVE HEALTH LLCFQM2026-02-05
00810178884612ViveCareVIVE HEALTH LLCFQM2026-02-05
08809302580652New Soosung Elastic Bandagesoosung medicalFQM2025-12-26
08809302580683New Soosung Elastic Bandagesoosung medicalFQM2025-12-26
08809302580928New Soosung Elastic Bandagesoosung medicalFQM2025-12-26
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08809302587538Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587545Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587552Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587569Soosung Elastic Bandagesoosung medicalFQM2025-12-11
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26975803530840GSOGroup Supply Organization Medical Technology(Shanghai) LtdFQM2025-11-30
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30840330705869ProCureTwin Med, LLCFQM2025-11-26
30840330705876ProCureTwin Med, LLCFQM2025-11-26
30840330705883ProCureTwin Med, LLCFQM2025-11-26
04250381827123Head bandageSpiggle & Theis Medizintechnik GmbHFQM2025-09-19
04250381827130Head bandageSpiggle & Theis Medizintechnik GmbHFQM2025-09-19
04250381827147Elastic head bandage with ear slipSpiggle & Theis Medizintechnik GmbHFQM2025-09-19
50192253065280CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15