FDA.reportPublic FDA data

TONOPORT BP Cuff for Adults, Large

Primary DI
04260671372028
Brand
TONOPORT BP Cuff for Adults, Large
Company
PAR Medizintechnik GmbH & Co. Kommanditgesellschaft
Model
2001589-213
Published
2020-03-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXQBlood Pressure Cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXQBlood Pressure CuffCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00742832731546PreviousGS10
04260671372028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00742832731546007428327315467428327315460742832731546
04260671372028042606713720284260671372028

GMDN Terms#

Term, Definition table
TermDefinition
Blood pressure cuff, reusableA band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is wrapped around the upper arm or the leg (thigh) of the patient. This is a reusable device which may be intended for single-patient or multi-patient reuse.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length638Millimeter
Width145Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00Keep dry.
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49302350700info@par-berlin.com

Regulatory Flags#

DUNS number
324233626
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260671371021TONOPORT VI2001589-2022024-12-12
04260671372561blood pressure cuff, Size M, for digital devicesA2534-m2020-12-21
04260671372578blood pressure cuff, Size L, for digital devicesA2534-l2020-12-21
04260671372585blood pressure cuff, Size XL, for digital devicesA2534-xl2020-12-21
04260671372592blood pressure cuff, Size XXL, for digital devicesA2534-xxl2020-12-21
04260671372547blood pressure cuff, Size XS, for digital devicesA2534-xs2020-12-21
04260671372554blood pressure cuff, Size S, for digital devicesA2534-s2020-12-21
04260671372004TONOPORT BP Cuff for Adults, Small2001589-2112020-03-06
04260671372011TONOPORT BP Cuff for Adults, Standard2001589-2122020-03-06
04260671372035TONOPORT BP Cuff for Adults, Extra-large2001589-2142020-03-06
04260671372202TONOPORT BP Single-Use Cuff for Adults, Small2001589-2322020-03-06
04260671372219TONOPORT BP Single-Use Cuff for Adults, Standard2001589-2332020-03-06
04260671372226TONOPORT BP Single-Use Cuff for Adults, Large2001589-2342020-03-06
04260671372233TONOPORT BP Single-Use Cuff for Adults, Extra-large2001589-2352020-03-06
00742832731522TONOPORT BP CUFF ADULT SMALL2001589-2112016-06-13
00742832731539TONOPORT BP CUFF ADULT STANDARD2001589-2122016-06-13
00742832731546TONOPORT BP CUFF ADULT LARGE2001589-2132016-06-13
00742832731553TONOPORT BP CUFF ADULT EXTRA LARGE2001589-2142016-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344111565MEDLINEMEDLINE INDUSTRIES, INC.DXQ2026-05-21
M3681097001GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M3682362X1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
10197344165346MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
10197344165377MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
10197344165391MEDLINEMEDLINE INDUSTRIES, INC.DXQ2025-11-14
10326053121521Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121538Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121545Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121552Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121569Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121576Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121583Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121590Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121606Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121613Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121620Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121637Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121644Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121651Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121668Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121675Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121682Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121699Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10326053121705Regard™Resource Optimization & Innovation, L.L.C.DXQ2024-12-02
10197344014514MEDLINEMEDLINE INDUSTRIES, INC.DXQ2024-09-02
10197344020645MedlineMEDLINE INDUSTRIES, INC.DXQ2024-03-27
M3682011GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2024-01-10
M368201BK1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2024-01-10
M368201BKC1GAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2024-01-10