FDA.reportPublic FDA data

RightSpotpH®

Primary DI
00861145002607
Brand
RightSpotpH®
Company
RIGHTBIO/METRICS INC.
Model
RSSB001
Device description
Small Bore Indicator
Published
2018-11-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JLLTubeless Analysis, Gastric Acidity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JLLTubeless Analysis, Gastric AcidityClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20861145002601PackageGS110In Commercial Distribution
40861145002605PackageGS1350In Commercial Distribution
00861145002607PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2086114500260120861145002601
4086114500260540861145002605
00861145002607008611450026078611450026070861145002607

GMDN Terms#

Term, Definition table
TermDefinition
pH meter IVDA manual, semi-automated, or automated instrument intended to be used for the qualitative and/or quantitative in vitro determination of the pH of a clinical specimen (i.e., its degree of acidity or alkalinity) by measuring hydrogen ion concentration.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature-40 Degrees Celsius52 Degrees Celsius
Storage Environment Temperature-40 Degrees Fahrenheit125 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
480-466-0041info@RightBioMetrics.com

Regulatory Flags#

DUNS number
964861012
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
40861145002605RightSpotpH®RSSB0012018-11-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979259840009PEPFASTRD Biomed (Changsha) LimitedJLL2025-12-23
06979259840016PEPFASTRD Biomed (Changsha) LimitedJLL2025-12-23
06979259840023PEPFASTRD Biomed (Changsha) LimitedJLL2025-12-23
05060590880401EnteralGBUK ENTERAL LIMITEDJLL2022-11-01
05060590880432EnteralGBUK ENTERAL LIMITEDJLL2022-11-01
05060590880692EnteralGBUK ENTERAL LIMITEDJLL2022-11-01
05060590880746EnteralGBUK ENTERAL LIMITEDJLL2022-11-01
40861145002605RightSpotpH®RIGHTBIO/METRICS INC.JLL2018-11-10
00709078006050FeedSafeWESTMED, INC.JLL2018-09-25
00709078006067FeedSafeWESTMED, INC.JLL2018-09-25
10709078006057FeedSafeWESTMED, INC.JLL2018-09-25
10709078006064FeedSafeWESTMED, INC.JLL2018-09-25