FDA.reportPublic FDA data

Advantage™

Primary DI
00634782553173
Brand
Advantage™
Company
AMERICAN DIAGNOSTIC CORP
Model
850-6013SA
Catalog number
850-6013SA
Device description
Cuff & Bladder-Digital,Small Adult, Navy
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DPWFlowmeter, Blood, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPWFlowmeter, Blood, CardiovascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970211000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970211000MICROLIFE AUTOMATIC BLOOD PRESSURE MONITORMicro Weiss Electronics1998-04-30DPW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00634782553173PackageGS115Not in Commercial Distribution
00634782053383PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00634782553173006347825531736347825531730634782553173
00634782053383006347820533836347820533830634782053383

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 Temperature-4 Degrees Fahrenheit131 Degrees Fahrenheit

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
00634782102258Adscope®608CFST608CFST2026-06-02
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

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Primary DI, Brand, Company table
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00888937027822CooperSurgical® Coopersurgical, Inc.DPW2025-09-25
00627987360158Dual Adhesive Strap1929803 Ontario CorpDPW2025-06-23
10627987360155Dual Adhesive Strap1929803 Ontario CorpDPW2025-06-23
07070554102690Medistim MiraQ Vascular SystemMedistim ASADPW2024-08-25
07070554103611Medistim MiraQ Vascular SystemMedistim ASADPW2024-08-25
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00813079022626VascuChek TransceiverREMINGTON MEDICAL, INC.DPW2024-08-23
00813079022633VascuChek ChargerREMINGTON MEDICAL, INC.DPW2024-08-23
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07070554103444Medistim MiraQ Vascular SystemMedistim ASADPW2024-04-12
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00627987360141Dual Adhesive Strap1929803 Ontario CorpDPW2023-03-03
10627987360148Dual Adhesive Strap1929803 Ontario CorpDPW2023-03-03
00627987360110Hydrogel Adhesive Strap1929803 Ontario CorpDPW2022-06-17
10627987360117Hydrogel Adhesive Strap1929803 Ontario CorpDPW2022-06-17
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