FDA.reportPublic FDA data

Sleepsense

Primary DI
07290012144462
Brand
Sleepsense
Company
SLP INC
Model
1396-Kit
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290012144462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290012144462072900121444627290012144462

GMDN Terms#

Term, Definition table
TermDefinition
Electrode/transducer strap, reusableA strip of material (e.g., fabric) intended to be used to hold electrodes and/or transducers (e.g., foetal monitoring transducers) in place on the body surface; it typically has fasteners (e.g., Velcro, buckle). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023572393
Device count
1
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290013818829NatusNA-13402016-09-20
07290013818836NatusNA-13412016-09-20
07290013818843NatusNA-15502016-09-20
07290013820464Sleepsense9100A5BP-Kit2016-09-20
07290008986526Sleepsense 1370-Kit 2016-09-20
07290008986533Sleepsense 1388-Kit 2016-09-20
07290008986540Sleepsense 1387-Kit 2016-09-20
07290008986601Sleepsense 1770-Kit 2016-09-20
07290008986618Sleepsense 1772-Kit 2016-09-20
07290008986632Sleepsense 9101PTP-Kit 2016-09-20
07290012144325Sleepsense 1368-Kit 2016-09-20
07290012144332Sleepsense 1369-Kit 2016-09-20
07290012144349Sleepsense 1391-Kit 2016-09-20
07290012144356Sleepsense 1389-KIT 2016-09-20
07290012144363Sleepsense 1450-KIT 2016-09-20
07290012144431Sleepsense 1399-Kit 2016-09-20
07290012144448Sleepsense 1398-Kit 2016-09-20
07290012144455Sleepsense 1397-Kit 2016-09-20
07290012144479Sleepsense 1771-2-Kit 2016-09-20
07290012144486Sleepsense 1771-Kit 2016-09-20