Lynn Medical - Ambulatory Kit

Primary DI
10851491007293
Brand
Lynn Medical - Ambulatory Kit
Company
Lynn Medical Instrument Co.
Model
311235
Catalog number
311235
Device description
Ambulatory Monitoring Kit - Kendall 235
Published
2018-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851491007293PackageGS110In Commercial Distribution
20851491007290PackageGS150In Commercial Distribution
30851491007297PackageGS120In Commercial Distribution
00851491007296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085149100729310851491007293
2085149100729020851491007290
3085149100729730851491007297
00851491007296008514910072968514910072960851491007296

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic long-term ambulatory recording support kitA collection of non-sterile, noninvasive devices intended to be used in conjunction with an electrocardiographic (ECG) long-term ambulatory recorder (holter monitor) to facilitate recording. It includes an ECG electrode(s), batteries (to power the recorder), devices intended to assist electrode application (e.g., razor, electrode placement guide, conductive gel, skin cleaning wipe, tape), and may include other patient-supportive devices (e.g., diary/notebook); the recorder is not included. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius32 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-596-6633customerservice@lynnmed.com

Regulatory Flags#

DUNS number
058810771
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
00851491007333AccuGelAG-50CL-HVAG-50CL-HV2017-02-13
00851491007364AccuGelAG-08AG-082017-02-13
00851491007340AccuGelAG-50AG-502017-02-13
00851491007531AccuSensor915-100915-1002020-08-31
10851491007538AccuSensor915-100915-1002020-08-31
00851491007548AccuSensor910-100910-1002020-06-25
00851491007487Direct IV Solutions - IV Start Kit2533-20G2533-20G2020-04-23
00851491007500Direct IV Solutions - IV Start Kit2534-20G2534-20G2020-04-23
00851491007517Direct IV Solutions - IV Start Kit2533-22G2533-22G2020-04-23
00851491007524Direct IV Solutions - IV Start Kit2534-22G2534-22G2020-04-23
20851491007481Direct IV Solutions - IV Start Kit2533-20G2533-20G2020-04-23
10851491007507Direct IV Solutions - IV Start Kit2534-20G2534-20G2020-04-23
10851491007514Direct IV Solutions - IV Start Kit2533-22G2533-22G2020-04-23
10851491007521Direct IV Solutions - IV Start Kit2534-22G2534-22G2020-04-23
00851491007470Lynn Medical - Ambulatory Kit3111353111352018-10-24
00851491007425Lynn Medical - Ambulatory Kit3112103112102018-10-10
00851491007432Lynn Medical - Ambulatory Kit3112123112122018-10-10
00851491007449Lynn Medical - Ambulatory Kit3112113112112018-10-10
00851491007456Lynn Medical - Ambulatory Kit3112133112132018-10-10
00851491007463Lynn Medical - Ambulatory Kit3112143112142018-10-10