Disposable cuff

GUDID 10840935107538

SUNTECH MEDICAL, INC.

Blood pressure cuff, reusable

Primary Device ID	10840935107538
NIH Device Record Key	c9894dac-d0b5-4126-8105-16ae0f15635c
Commercial Distribution Status	In Commercial Distribution
Brand Name	Disposable cuff
Version Model Number	98-0700-02
Company DUNS	148191133
Company Name	SUNTECH MEDICAL, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com
Phone	1-919-654-2300
Email	UDI_MAIL@suntechmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840935107538 [Primary]
GS1	20840935107535 [Package] Package: Box [20 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K080854

FDA Product Code

DXQ	Blood Pressure Cuff

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2019-07-22
Device Publish Date	2017-05-25

On-Brand Devices [Disposable cuff]

10840935106371	98-0399-26
10840935106128	98-0399-56
10840935106111	98-0399-57
10840935105138	98-0799-17
10840935105084	98-0799-07
10840935104230	98-0799-87
10840935103844	98-0399-A6
10840935103752	97-1108-03
10840935103684	98-0799-86
10840935103639	98-0399-D7
10840935103622	98-0399-D6
10840935103141	98-0399-37
10840935103134	98-0399-36
10840935102366	98-0799-77
10840935102304	98-0799-76
10840935100850	98-0399-G6
10840935100843	98-0399-G7
10840935100652	98-0799-47
10840935100645	98-0799-46
10840935100515	98-0799-37
10840935100492	98-0799-36
10840935100331	98-0799-27
10840935100317	98-0799-26
10840935100072	98-0799-16
10840935100027	98-0799-06
20840935107658	98-0399-C8
10840935106364	98-0399-28
10840935106265	98-0400-38
10840935106081	98-0399-58
10840935104247	98-0799-88
10840935103646	98-0399-D8
10840935102397	98-0799-78
10840935100805	98-0399-A8
10840935100782	98-0399-G8
10840935100669	98-0799-48
10840935100539	98-0799-38
10840935100348	98-0799-28
10840935100324	98-0399-78
10840935100119	98-0799-18
10840935100034	98-0799-08
20840935108402	97-1108-12
20840935108396	97-1108-11
20840935108389	97-1108-10
20840935108372	97-1108-09
20840935108211	98-0399-7K
20840935108204	98-0399-5K
20840935108198	98-0399-2K
20840935108181	98-0399-1K
20840935108174	98-0399-0K
20840935108167	98-0799-6K