FDA.report

Adcuff™

Primary DI
00634782844608
Brand
Adcuff™
Company
AMERICAN DIAGNOSTIC CORP
Model
8400X3-10
Catalog number
8400X3-10
Device description
SPU Cuff, 2 Tube,Lrg Adult, Female Conn
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
DXQBlood Pressure Cuff

Product Code Classifications

CodeDeviceSpecialtyClass
DXQBlood Pressure CuffCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00634782844608PackageGS110Not in Commercial Distribution
00634782044770PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00634782844608006347828446086347828446080634782844608
00634782044770006347820447706347820447700634782044770

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity

Sterilization Methods

Method

Contacts

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

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00634782603106Adtemp™ 424N-200424N-2002025-02-05
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00634782600679Adscope®606RGBK606RGBK2023-01-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00634782902636Adcuff™ AMERICAN DIAGNOSTIC CORPDXQ2026-02-23
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M36823552N1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
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M36823562N1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823562X1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
M36823572A1GRAHAM FIELDGF HEALTH PRODUCTS, INC.DXQ2026-02-20
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