FDA.reportPublic FDA data

Fastlock

Primary DI
08718627410813
Brand
Fastlock
Company
A & E MEDICAL CORPORATION
Model
PC175M18
Published
2016-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080621000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080621000FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01European Custom Manufacturing BV2008-04-29DSA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08718627410820PackageGS110In Commercial Distribution
08718627410813PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08718627410820087186274108208718627410820
08718627410813087186274108138718627410813

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.

Regulatory Flags#

DUNS number
173770868
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841291105305Myo/Wire021-0112016-03-21
08718627410004MYO/Wire® Ultra-Thin Temporary Pacing Wires AU0101022015-11-05
08718627410028MYO/Wire® Ultra-Thin Temporary Pacing Wires BM1804ABB2015-11-10
08718627410042MYO/Wire® Ultra-Thin Temporary Pacing Wires BM1804ABBN2015-11-10
08718627410066MYO/Wire® Ultra-Thin Temporary Pacing Wires BM2004ABB2015-11-10
08718627410080MYO/Wire® Ultra-Thin Temporary Pacing Wires BM2004ABBD2015-11-10
08718627410103MYO/Wire® Ultra-Thin Temporary Pacing Wires BM2008ABBSN2015-11-10
08718627410127MYO/Wire® Ultra-Thin Temporary Pacing Wires BM2504ABB2015-11-10
08718627410141MYO/Wire® Ultra-Thin Temporary Pacing Wires BM2504ABBD2015-11-10
08718627410165MYO/Wire® Ultra-Thin Temporary Pacing Wires BM2504AWWD2015-11-10
08718627410189MYO/Wire® Ultra-Thin Temporary Pacing Wires BM604ABB2015-11-10
08718627410226MYO/Wire® Ultra-Thin Temporary Pacing Wires BM604ABBDS2015-11-10
08718627410264MYO/Wire® Ultra-Thin Temporary Pacing Wires BM604ABBSTR2015-11-10
08718627410288MYO/Wire® Ultra-Thin Temporary Pacing Wires BM604ABW2015-11-10
08718627410301MYO/Wire® Ultra-Thin Temporary Pacing Wires BM604ACBBGSTR2015-11-10
08718627410325MYO/Wire® Ultra-Thin Temporary Pacing Wires BM604ACWWStr2015-11-10
08718627410349MYO/Wire® Ultra-Thin Temporary Pacing Wires BM604PBB2015-11-10
08718627410363MYO/Wire® Ultra-Thin Temporary Pacing Wires BM604PWWMSTR2015-11-10
08718627410387MYO/Wire® Ultra-Thin Temporary Pacing Wires BM608-12ABBG2015-11-05
08718627410400MYO/Wire® Ultra-Thin Temporary Pacing Wires BM608-8ACBB2015-11-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G662ME590015H1MaguireMaguire Enterprises, Inc.DSA2026-09-24
00191506063214OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDSA2026-09-20
03700506301775INTEGRAL PROCESS Cables & LeadwiresNISSHA MEDICAL TECHNOLOGIES SASDSA2026-08-27
G662ME590032R1MaguireMaguire Enterprises, Inc.DSA2026-08-25
00840416607130FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607147FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607154FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607161FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607178FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
00840416607185FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-17
08720938410383Cardiac, 10-Lead, IEC, Basic Monitoring KitFysicon B.V.DSA2026-08-14
08720938410390Cardiac, 10-Lead, AHA, Basic Monitoring KitFysicon B.V.DSA2026-08-14
08720938410406IR, 5-Lead, IEC, Basic Monitoring KitFysicon B.V.DSA2026-08-14
08720938410413IR, 5-Lead, AHA, Basic Monitoring KitFysicon B.V.DSA2026-08-14
08720938410420ACIST FFR Connection KitFysicon B.V.DSA2026-08-14
08720938410437Volcano (Philips) FFR Connection KitFysicon B.V.DSA2026-08-14
08720938410444ABBOTT FFR Connection KitFysicon B.V.DSA2026-08-14
08720938410451BOSTON FFR Connection KitFysicon B.V.DSA2026-08-14
00840416607079FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607086FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607093FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607109FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607116FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840416607123FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-08-03
00840309445672Viva ComfortTiger Supplies IncDSA2026-08-01
00840309445689Viva ComfortTiger Supplies IncDSA2026-08-01
G662ME3641MaguireMaguire Enterprises, Inc.DSA2026-07-31
G662ME5900951MaguireMaguire Enterprises, Inc.DSA2026-07-29
G662ME590333B1MaguireMaguire Enterprises, Inc.DSA2026-07-29
G662ME590280L1MaguireMaguire Enterprises, Inc.DSA2026-07-28