FDA.reportPublic FDA data

FCP Bandage

Primary DI
07290017050126
Brand
FCP Bandage
Company
FIRST CARE PRODUCTS LTD
Model
FCP12
Device description
"FCP12 - 6"" Bandage w/2nd Mobile Pad (White)"
Published
2020-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAXTourniquet, Nonpneumatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAXTourniquet, NonpneumaticGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017050126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017050126072900170501267290017050126

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal paracentesis needle, reprocessedA sterile, sharp bevel-edged, hollow tubular metal instrument used to perform therapeutic or diagnostic aspiration of fluids/air from the abdominal cavity. It may be used for the placement/operation of a paracentesis catheter or used directly without a catheter. It is typically made of high-grade stainless steel and may have an attached stopcock to control the aspiration process. The device is commonly used to remove ascites fluid from the peritoneal cavity. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-737-7978info@ps-med.com

Regulatory Flags#

DUNS number
514694454
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017050485The Quick-T tourniquetQuick-T2024-10-13
07290017050072FCP BandageFCP072020-08-24
07290017050201FCP BandageT3 Military2020-08-26
07290017050225FCP BandageT6 Military2020-08-26
07290017050249FCP Bandage"Gauze 4"""Medical Elastic Wrap 4’’2020-08-26
07290017050096FCP BandageFCP092020-08-25
07290017050102FCP BandageFCP102020-08-25
07290017050119FCP BandageFCP112020-08-25
07290017050133FCP BandageFCP09+2020-08-25
07290017050140FCP BandageFCP10+2020-08-25
07290017050157FCP BandageWoundStop Care1WS-052020-08-25
07290017050164FCP BandageWoundStop HomeCareWS-042020-08-25
07290017050171FCP BandageFCP10T2020-08-25
07290017050188FCP BandageWoundStop Care1+WS-062020-08-25
07290017050010FCP BandageFCP012020-08-24
07290017050027FCP BandageFCP022020-08-24
07290017050034FCP BandageFCP032020-08-24
07290017050058FCP BandageFCP052020-08-24
07290017050065FCP BandageFCP062020-08-24
07290017050256FCP Bandage"Gauze 6""""Medical Elastic Wrap 6"""2020-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20888277414249MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-20
20888277717388MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-08
40080196774662MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-08
40080196781462MEDLINEMEDLINE INDUSTRIES, INC.GAX2026-05-08
20665973032393DukalDukal LLCGAX2025-04-08
20665973032409DukalDukal LLCGAX2025-04-08
20197344105363MEDLINEMEDLINE INDUSTRIES, INC.GAX2025-03-24
30197344006230MEDLINEMEDLINE INDUSTRIES, INC.GAX2025-03-24
00087453143478HysynalHYGENIC CORPORATION, THEGAX2025-03-10
30382903671992BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-20
30382903672050BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-20
30382903671985BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-13
30382903672098BD Vacutainer® Stretch TourniquetBECTON, DICKINSON AND COMPANYGAX2024-03-13
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