NA

Primary DI
10888551034814
Brand
NA
Company
STERILMED, INC.
Model
STJ11161M
Catalog number
STJ11161M
Device description
FEMORAL COMPRESSION SYSTEM MODIFIED -- PUMP AND GAUGE NOT INCLUDED --
Published
2016-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NMFClamp, vascular, reprocessed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NMFClamp, Vascular, ReprocessedCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120204000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120204000REPROCESSED FEMORAL COMPRESSION DEVICESterilmed, Inc.2012-04-03NMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888551034814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088855103481410888551034814

GMDN Terms#

Term, Definition table
TermDefinition
Femoral artery compression system, manual, single-useA non-sterile, noninvasive, non-powered device intended to provide compression for haemostasis to the puncture site on a patient having undergone femoral artery catheterization, typically as an alternative to direct hand pressure; it may in addition be used on brachial and radial arteries or after venipuncture. The compressing portion could be one of a variety of designs (e.g., disc affixed to a handle, ball, dome or roller, manually-inflatable bulb) and is typically held in place with a frame, bandage, or straps secured around the patient's hips/thigh. It may be used in conjunction with dressings/haemostatic agents (not included). This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(888)541-0078customerservice@sterilmed.com

Regulatory Flags#

DUNS number
175899459
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888551001205NAMED5455SLMED5455SL2016-09-22
10888551004312NAMID7BA407BA402018-06-18
10888551004329NAMID7BA40D7BA40D2018-06-18
10888551017862NALIN5052-1865052-1862018-06-18
10888551035224NASTR1608-2-111608-2-112018-06-18
10888551045292NASYN03.312.090SYN03.312.0902019-11-15
10888551045308NASYN03.312.120SYN03.312.1202019-11-15
10888551045315NASYN394.88SYN394.882019-11-15
10888551045322NASYN03.312.680SYN03.312.6802019-11-15
10888551045339NASYN394.89SYN394.892019-11-15
10888551045346NASYN394.90SYN394.902019-11-15
10888551045353NASYN394.91SYN394.912019-11-15
10888551045360NASYN394.92SYN394.922019-11-15
10888551045377NASYN03.312.620SYN03.312.6202019-11-15
10888551045384NASYN03.312.650SYN03.312.6502019-11-15
10888551045391NASYN03.312.710SYN03.312.7102019-11-15
10888551045407NASYN03.312.740SYN03.312.7402019-11-15
10888551045414NASYN03.312.590SYN03.312.5902019-11-15
10888551045421NASYN03.312.350SYN03.312.3502019-11-15
10888551045438NASYN03.312.380SYN03.312.3802019-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888551039482NASTERILMED, INC.NMF2016-09-22