FDA.reportPublic FDA data

KIT, PANEL, PL691, 5-PCS

Primary DI
00812664024137
Brand
KIT, PANEL, PL691, 5-PCS
Company
STANLEY SECURITY SOLUTIONS, INC.
Model
RP131K
Catalog number
RP131K
Device description
KIT, PANEL, PL691, 5-PCS
Published
2021-07-10
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
IQASYSTEM, ENVIRONMENTAL CONTROL, POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQASystem, Environmental Control, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812664024137PackageGS15In Commercial Distribution
00812664023710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812664024137008126640241378126640241370812664024137
00812664023710008126640237108126640237100812664023710

GMDN Terms#

Term, Definition table
TermDefinition
Nurse call system alarmAn electronic device intended to provide an audible sound and/or a visual display, typically coloured flashing lights or scrolling text, to notify a medical professional that (urgent) assistance is needed by a patient. It may be in the form of dome lights, basic visual display screens, and/or beeping devices which are triggered by manual or automatic alert activators (e.g., bedside push-button, ambulatory fall sensor, bed occupancy sensor) [not included]; it may function independently or as a component of a nurse call system via the healthcare facility hardwired or wireless network.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)380-8883Support_all@sbdinc.com

Regulatory Flags#

DUNS number
196880520
Device count
1
DM exempt
false
Premarket exempt
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840948101295BED PAD,45DAY,6 PACK,BSM-1W-6950802021-07-15
10840948101769BED PAD,180DAY,6 PACK,BSM-2B-6951002021-07-15
10840948101776BED PAD,1YR,6 PACK,BSM-4-6951102021-07-15
10840948101783CHAIR PAD,180DAY,6 PACK,CSM-3B952502021-07-15
10840948101790CHAIR PAD,1YR,6 PACK,CSM-4952602021-07-15
10840948101806CHAIR PAD,45DAY,6 PACK,CSM-2W953302021-07-15
108409481018131 YEAR TIMED BED PAD,SIX PACK961202021-07-15
108409481018201 YEAR TIMED CHAIR PAD,SIX PACK961602021-07-15
00812664024144DUMMY PLUG, 1/4" PLASTIC - 5 EAJK018KJK018K2021-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812664025127TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-19
00812664024700TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664024717TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664024724TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664024731TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664024892TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664024908TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664024915TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664025134TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00812664025141TekTone Sound & Signal Mfg., Inc.TEKTONE SOUND AND SIGNAL, MFG., INC.IQA2026-08-18
00840828197007GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-08-18
00840828196864GEN4 DIRECT ACCESSCURBELL MEDICAL PRODUCTS, INC.IQA2026-07-23
00840828196871GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-23
00840828196758GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196789GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196796GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196802GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196819GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196826GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196833GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196840GEN4 DIGITALCURBELL MEDICAL PRODUCTS, INC.IQA2026-07-08
00840828196666GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-06-09
00840828196673GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-06-09
00840828196475GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196482GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196499GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196505GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196512GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196529GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27
00840828196536GEN4 INTERACTIVECURBELL MEDICAL PRODUCTS, INC.IQA2026-05-27