FDA.report

SunTech APC

Primary DI
10840935110422
Brand
SunTech APC
Company
SUNTECH MEDICAL, INC.
Model
98-0085-72
Published
2023-06-09
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
false

Related Records

Product Codes

CodeName
DXQBlood Pressure Cuff

Product Code Classifications

CodeDeviceSpecialtyClass
DXQBlood Pressure CuffCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10840935110422PrimaryGS10

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1-919-654-2300UDI_mail@suntechmed.com

Regulatory Flags

DUNS number
148191133
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
true
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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10840935110293SunTech APC98-0080-392023-06-09
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10840935110316SunTech APC98-0082-012023-06-09
10840935110323SunTech APC98-0082-022023-06-09
10840935110330SunTech APC98-0082-052023-06-09

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