FDA.reportPublic FDA data

NA

Primary DI
00813079021391
Brand
NA
Company
REMINGTON MEDICAL, INC.
Model
FL-601-97-12BNS
Catalog number
FL-601-97-12BNS
Device description
12 Foot Disposable Extension Cable with Safe Connect / Screw-Down
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSACABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813079021391PrimaryGS10
80813079021397Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813079021391008130790213918130790213910813079021391
8081307902139780813079021397

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, single-useA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3.658E+15Femtometer

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)989-0057Quality@Remmed.com

Regulatory Flags#

DUNS number
788472314
Device count
25
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00813079022671VascuChek Speaker DockVC-SD-01VC-SD-012025-11-27
00813079022688VascuChek KitVC-KIT-02VC-KIT-022025-11-27
10813079022616VascuChek Surgical ProbeVC-SP-01VC-SP-012024-08-23
00813079022626VascuChek TransceiverVC-TRX-01VC-TRX-012024-08-23
00813079022633VascuChek ChargerVC-CH-01VC-CH-012024-08-23
00813079022640VascuChek KitVC-KIT-01VC-Kit-012024-08-23
10813079022654VascuChek Clinical ProbeVC-CP-01VC-CP-012024-08-23
10813079020223Bone Marrow "I" Needle1501-I1501-I2020-09-24
20813079020237Bone Marrow "I" Needle1601-I1601-I2020-09-24
10813079020247Bone Marrow "J" Needle Double Diamond TipJD-1104JD-11042020-09-24
20813079020251Bone Marrow "J" Needle Double Diamond TipJD-1106JD-11062020-09-24
80813079020260Bone Marrow "J" Needle with Double Diamond TipJD-1104-NSJD-1104-NS2020-09-24
20813079020275Guidewire Introducer Needle Winged Base PlateBGWI-1802BGWI-18022020-09-24
20813079020299Guidewire Introducer Needle Winged Base PlateBGWI-1902BGWI-19022020-09-24
20813079020305Guidewire Introducer NeedleGWI-1802GWI-18022020-09-24
10813079020322Guidewire Introducer Needle Square Hub Access NeedleGWI-1820WWGWI-1820WW2020-09-24
20813079020336Guidewire Introducer NeedleGWI-1902GWI-19022020-09-24
10813079020346Guidewire Introducer Needle Square Hub Access NeedleGWI-1902WWGWI-1902WW2020-09-24
10813079020360Breast Needle LocatorBNL-2003BNL-20032020-09-24

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