FDA.reportPublic FDA data

Sandhill Scientific

Primary DI
B019ZAIBL560
Brand
Sandhill Scientific
Company
DIVERSATEK HEALTHCARE, INC.
Model
ZAI-BL-56
Catalog number
ZAI-BL-56
Device description
LPR Probe, Dual pH (Esophageal), LPR Acid, Locator Port 6cm
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFTElectrode, Ph, Stomach
FFXSystem, Gastrointestinal Motility (Electrical)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFTElectrode, Ph, StomachGastroenterology, Urology1
FFXSystem, Gastrointestinal Motility (Electrical)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012232000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012232000INSIGHT, MODEL S980000Sandhill Scientific, Inc.2002-06-07FFX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B019ZAIBL560PrimaryHIBCC0
00816734022245SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816734022245008167340222458167340222450816734022245

GMDN Terms#

Term, Definition table
TermDefinition
Oesophageal motility analysis systemAn assembly of devices designed to evaluate peristaltic motility in the oesophagus by measuring pressure on an intraluminal catheter/probe at several points (including LES); it also measures pH, respiration, and swallowing with appropriate sensors. In addition to a monitor display, computer, and software, it usually includes nonperfusion catheters to measure pressures directly and/or perfusion catheters and extracorporeal transducers to measure pressure indirectly. The system is intended to evaluate patients with dysphagia, gastro-oesophageal reflux disease (GERD), and/or noncardiac chest pain; it is also used to assess connective tissue and neuromuscular disease.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge6.9French

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-558-6408sales@diversatekhc.com

Regulatory Flags#

DUNS number
030650113
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
true
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
00816734021286InnerVision®1465-401465-402018-09-18
00816734021293InnerVision®1465-501465-502018-09-18
00816734021217InnerVision®1450-021450-022018-09-18
00816734021224InnerVision®1450-401450-402018-09-18
00816734021231InnerVision®1450-501450-502018-09-18
00816734021248InnerVision®1450-561450-562018-09-18
00816734021255InnerVision®1455-401455-402018-09-18
00816734021262InnerVision®1455-501455-502018-09-18
00816734021279InnerVision®1455-561455-562018-09-18
00816734021309InnerVision®1465-561465-562018-09-18
00816734023518BullDog®1203-401203-402025-12-05
10816734023515BullDog®1203-401203-402025-12-05
M78312011160Diversatek Healthcare1201-1161201-1162025-11-14
00816734021682Diversatek HealthcareA86-1070A86-10702023-06-30
00816734021835Diversatek HealthcareA86-4300-10A86-4300-102023-06-30
00816734021859Diversatek HealthcareA86-5070A86-50702023-06-30
00816734022825Zvu®ZVU-3ZVU-32020-11-06
M78312011161Diversatek Healthcare1201-1161201-1162025-11-14
00816734023433Diversatek HealthcareMANO-KITMANO-KIT2025-05-16
00816734023440Diversatek HealthcareHRIM-KITHRIM-KIT2025-05-16

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Primary DI, Brand, Company table
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00678467508393Mui ScientificH & A Mui Enterprises IncFFX2025-11-04
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10678467508345Mui ScientificH & A Mui Enterprises IncFFX2025-08-26
00678467508348Mui ScientificH & A Mui Enterprises IncFFX2025-08-26
10678467508338Mui ScientificH & A Mui Enterprises IncFFX2025-08-21
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10884521855441ManoScanGiven Imaging, Inc.FFX2025-08-21
10678467508307Mui ScientificH & A Mui Enterprises IncFFX2025-07-22
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00678467508270Mui ScientificH & A Mui Enterprises IncFFX2025-06-11
00678467508287Mui ScientificH & A Mui Enterprises IncFFX2025-06-11
00816734023433Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16
00816734023440Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16
10678467508253Mui ScientificH & A Mui Enterprises IncFFX2025-04-15
10678467508239Mui ScientificH & A Mui Enterprises IncFFX2025-04-10
10678467508246Mui ScientificH & A Mui Enterprises IncFFX2025-04-10
18717775956614MPP-PlusMedical Measurement Systems B.V.FFX2025-02-21