Sleepsense

GUDID 07290013819277

S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD

Respiratory oxygen sensor

• Primary Device ID: 07290013819277
• NIH Device Record Key: e66517f2-b955-4b31-bb65-d96aef768ef2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sleepsense
• Version Model Number: 8110-T100A300
• Company DUNS: 600632715
• Company Name: S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290013819277 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100077

FDA Product Code

• DQA: Oximeter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

On-Brand Devices [Sleepsense]

• 07290013819697: 5100
• 07290013819314: 9010NX
• 07290013819284: 8110-T100P300
• 07290013819277: 8110-T100A300
• 07290013819260: 8110-T100A090
• 07290013819239: 1350SN
• 07290013819116: 9007-L150
• 07290013819109: 9007-L120
• 07290013819093: PS005C
• 07290013819086: 1435
• 07290013819000: 1475S
• 07290013818935: PS065
• 07290013818867: 1585
• 07290013818522: 1216
• 07290013818485: 1479
• 07290013818157: 14833
• 07290013818119: 1483P
• 07290013818102: 1477P
• 07290013818096: 1475P
• 07290013818089: 1474P
• 07290013818072: 1478P
• 07290013817990: 9153A6
• 07290013817976: 1584
• 07290013817952: 1777
• 07290013817945: 1727
• 07290013817938: 1483
• 07290013817921: 1267
• 07290013817907: 1583
• 07290013817891: 1482
• 07290013817884: 1466-H
• 07290013817877: 1466
• 07290013817860: 9152S
• 07290013817853: 9151S
• 07290013817815: 1776S
• 07290013817754: 1470
• 07290013817747: 1423
• 07290013817730: 1255
• 07290013817723: 1405
• 07290013817631: 9100P-Kit
• 07290013817556: 1771S
• 07290013817532: 1422-H-S
• 07290013817518: 1478
• 07290013817501: 1477
• 07290013817426: 1475
• 07290013817419: 1474
• 07290013817341: PS026
• 07290013817266: 1473
• 07290013817105: 1472
• 07290013817099: 1471
• 07290013385932: 1582