FDA.reportPublic FDA data

Compress Bandages, Offset, Sterile

Primary DI
00616784319421
Brand
Compress Bandages, Offset, Sterile
Company
DYNAREX CORPORATION
Model
3194
Device description
Compress Bandages, Offset, Sterile, 4"
Published
2021-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

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
00616784319438PrimaryGS10
00616784319421Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784319438006167843194386167843194380616784319438
00616784319421006167843194216167843194210616784319421

GMDN Terms#

Term, Definition table
TermDefinition
Absorbent wound compression padA rolled strip of fabric material (e.g., non-woven polyester) intended to be applied around a wound (e.g., venous stasis ulcer of the leg) as a supplemental padded layer for a pressure bandage, primarily to help evenly distribute pressure and absorb exudates during the compression treatment of the wound. It is intended for use in the home or a clinical setting. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
700
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
00840117343764Dynacare Necessities Complete Kit13742026-05-28
00616784812137Drape Sheets, Tissue 2-ply, White, 40" x 48"81212021-09-01
00616784812236Drape Sheets81222021-09-01
00616784812335Drape Sheets81232021-09-01
00616784813134Drape Sheets, Tissue 2-ply, White, 40" x 60"81312021-09-01
00616784813233Drape Sheets81322021-09-01
00616784813332Drape Sheets81332021-09-01
00616784814131Drape Sheets, Tissue 2-ply, White81412021-09-01
00616784815039Drape Sheets, Tissue 2-ply, Blue, 40" x 90"81502021-09-01
00616784815138Drape Sheets, Tissue 2-Ply, white, 40" x 90"81512021-09-01
00616784816135Pillow Cases, Tissue / Poly 2-ply, 21" x 30", White81612021-09-01
00616784890128SecureSafe Safety Insulin Syringe89012017-10-16
00616784890425SecureSafe Safety Insulin Syringe89042017-10-16
00616784892825SecureSafe Syringes With Safety Needle, Non-Toxic, 3 ML, Luer Lock89282017-10-16
00616784711720Disposable Ear Specula Tips For Diagnostic Otoscopes, Adult, 4.25 mm71172021-05-21
00616784418025Bandage Shears 7.5" (19.1 cm) Black41802020-11-08
00616784418124Bandage Shears 7.5" (19.1 cm) Blue41812020-11-08
00616784418223Bandage Shears 7.5" (19.1 cm) Magenta41822020-11-08
00616784418322Bandage Shears 7.5" (19.1 cm) Orange41832020-11-08
00616784418421Bandage Shears 7.5" (19.1 cm) Purple41842020-11-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809302580645New Soosung Elastic Bandagesoosung medicalFQM2025-12-26
08809302580676New Soosung Elastic Bandagesoosung medicalFQM2025-12-26
08809302580911New Soosung Elastic Bandagesoosung medicalFQM2025-12-26
08809302580867New Soosung Elastic Bandagesoosung medicalFQM2025-12-24
08809302587217Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587224Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587231Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587248Soosung Elastic Bandagesoosung medicalFQM2025-12-11
10080196571925MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-10-20
10192253065282CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15
10192253065299CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15
10192253065305CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15
10192253065312CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15
10080196278237MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196691159MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196745593MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196745630MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196745647MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196745722MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10080196745739MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-08-14
10192253049251DermaceaCardinal Health 200, LLCFQM2025-07-21
10192253049268DermaceaCardinal Health 200, LLCFQM2025-07-21
10192253049275DermaceaCardinal Health 200, LLCFQM2025-07-21
10192253049282DermaceaCardinal Health 200, LLCFQM2025-07-21
10080196990733MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-06-10
10080196789207MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-06-02
10080196823536MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-05-30
10080196692378MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-05-29
10080196823543MEDLINEMEDLINE INDUSTRIES, INC.FQM2025-05-29
10097604110577Tronex International, Inc.TRONEX INTERNATIONAL, INC.FQM2025-05-05