FDA.reportPublic FDA data

Adcuff™

Primary DI
00634782568931
Brand
Adcuff™
Company
AMERICAN DIAGNOSTIC CORP
Model
845-13TN-1
Catalog number
845-13TN-1
Device description
ADCUFF & Bladder, 1 Tube,Thigh, Navy, LF
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
00634782568931PackageGS18In Commercial Distribution
00634782069261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00634782568931006347825689316347825689310634782568931
00634782069261006347820692616347820692610634782069261

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
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-232-2670info@adctoday.com

Regulatory Flags#

DUNS number
108999095
Device count
1
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
00634782603045ADC54202542022026-03-31
00634782603052ADC54203542032026-03-31
00634782603069ADC54204542042026-03-31
00634782603076ADC54205542052026-03-31
00634782098384Adscope®603-04W603-04W2026-03-30
00634782100209Adscope®608-12COP608-12COP2026-03-30
00634782100216Adscope®608-12G608-12G2026-03-30
00634782100223Adscope®608-12I608-12I2026-03-30
00634782100230Adscope®608-12ST608-12ST2026-03-30
00634782100247Adscope®608-12MBK608-12MBK2026-03-30
00634782100254Adscope®608-12RGBK608-12RGBK2026-03-30
00634782100261Adscope®608-12RGW608-12RGW2026-03-30
00634782100834Adscope®608-12BK608-12BK2026-03-30
00634782101190Adscope®608-01MBK608-01MBK2026-03-30
00634782101299Adsoft®602-078BK1Q602-078BK1Q2026-03-30
00634782101305Adsoft®602-078PR1Q602-078PR1Q2026-03-30
00634782101312Adsoft®602-078TQ1Q602-078TQ1Q2026-03-30
00634782101329Adsoft®602-078G1Q602-078G1Q2026-03-30
00634782101336Adsoft®602-078Y1Q602-078Y1Q2026-03-30
00634782101343Adsoft®602-078P1Q602-078P1Q2026-03-30

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