FDA.reportPublic FDA data

PREFERRED MEDICAL PRODUCTS LLC

Primary DI
00680211003276
Brand
PREFERRED MEDICAL PRODUCTS LLC
Company
PREFERRED MEDICAL PRODUCTS, LLC
Model
C-ARM 2454
Catalog number
C-ARM 2454
Device description
STERILE DISPOSABLE EQUIPMENT COVER- C-ARM DRAPE W/ TAIL
Published
2026-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JAASystem, X-Ray, Fluoroscopic, Image-Intensified

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K863853000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K863853000EAZY COVERSSuperior Medical Products1987-03-06JAA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10680211003273PackageGS120In Commercial Distribution
00680211003276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1068021100327310680211003273
00680211003276006802110032766802110032760680211003276

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Regulatory Flags#

DUNS number
161770292
Device count
1
DM exempt
false
Premarket exempt
false
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
00680211002040PREFERRED MEDICAL PRODUCTS, LLCPC-0896 W/BPC-0896 W/B2016-08-30
00680211002057PREFERRED MEDICAL PRODUCTS, LLCPC-0896-TFPC-0896-TF2016-08-30
00680211002064PREFERRED MEDICAL PRODUCTS, LLCPC-1.3836 W/SPC-1.3836 W/S2016-08-30
00680211002071PREFERRED MEDICAL PRODUCTS, LLCPC-1000PC-10002016-08-30
00680211002088PREFERRED MEDICAL PRODUCTS, LLCPC-1072-TFPC-1072-TF2016-08-30
00680211002095PREFERRED MEDICAL PRODUCTS, LLCPC-1480-TFPC-1480-TF2016-08-30
00680211002101PREFERRED MEDICAL PRODUCTS, LLCPD-2754PD-27542016-08-30
00680211002118PREFERRED MEDICAL PRODUCTS, LLCPD-3624PD-36242016-08-30
00680211002125PREFERRED MEDICAL PRODUCTS, LLCPD-4470PD-44702016-08-30
00680211002132PREFERRED MEDICAL PRODUCTS, LLCPD-4482PD-44822016-08-30
00680211002149PREFERRED MEDICAL PRODUCTS, LLCPD-4545PD-45452016-08-30
00680211002156PREFERRED MEDICAL PRODUCTS, LLCPD-5454PD-54542016-08-30
00680211002163PREFERRED MEDICAL PRODUCTS, LLCPD-5470PD-54702016-08-30
00680211002170PREFERRED MEDICAL PRODUCTS, LLCPD-5490PD-54902016-08-30
00680211002187PREFERRED MEDICAL PRODUCTS, LLCQC-EZ-12QC-EZ-122016-08-30
00680211002194PREFERRED MEDICAL PRODUCTS, LLCQC-EZ-20QC-EZ-202016-08-30
00680211002200PREFERRED MEDICAL PRODUCTS, LLCQC-EZ-2015QC-EZ-20152016-08-30
00680211002217PREFERRED MEDICAL PRODUCTS, LLCQC-EZ-28QC-EZ-282016-08-30
00680211002224PREFERRED MEDICAL PRODUCTS, LLCQC-EZ-3014.5QC-EZ-3014.52016-08-30
00680211002231PREFERRED MEDICAL PRODUCTS, LLCQC-EZ-3036QC-EZ-30362016-08-30

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