Embla

GUDID 07290013818003

S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD

Polysomnography analyser

• Primary Device ID: 07290013818003
• NIH Device Record Key: afc57b7c-318b-48a4-8080-4b1d52cf5f21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Embla
• Version Model Number: 11521
• 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	07290013818003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042253

FDA Product Code

• MNR: Ventilatory Effort Recorder

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 [Embla]

• 07290013818973: 1420448
• 07290013818966: 1420447
• 07290013818010: 11522
• 07290013818003: 11521
• 07290013817327: 4140099
• 07290013817310: 4140072
• 07290013817303: 1420406
• 07290013817297: 4140108
• 07290013817280: 4140073
• 07290013817273: 1451056
• 07290013817204: 1420446
• 07290013817198: 4140114
• 07290013817181: 4140087
• 07290013817174: 4140088
• 07290013817167: 4140089
• 07290013817150: 4140090
• 07290013817143: 4140064
• 07290013817136: 4140096
• 07290013817129: 4140095
• 07290013817112: 1420405
• 07290013817082: 4140069
• 07290013817075: 4140067
• 07290013817068: 4140094
• 07290013817044: 4140092
• 07290013817037: 4140091
• 07290013385994: 1440011
• 07290013385987: 1421102
• 07290013385970: 1421101
• 07290013385963: 1421100
• 07290013385956: 1421241
• 07290013385949: 1421240
• 07290013385925: 1440010
• 07290013385918: 1440021
• 07290013385901: 1420430
• 07290013385895: 1420445
• 07290013385888: 1420615
• 07290013385871: 1420440
• 07290013385864: 1420435
• 07290013385857: 1420431
• 07290013385840: 1420610
• 07290013385833: 1420605
• 07290013385826: 1420600