FDA.reportPublic FDA data

Owlet

Primary DI
00810099091601
Brand
Owlet
Company
Owlet Baby Care, Inc.
Model
YHW-6
Catalog number
YHW-6003
Device description
Owlet Smart Thermometer - Infrared Thermometer
Published
2026-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
SDVClinical Electronic Thermometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SDVClinical Electronic ThermometerGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810099091601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810099091601008100990916018100990916010810099091601

Regulatory Flags#

DUNS number
079422657
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
00810099090987Dream Sock Monitoring System - Mint OSS 3.0-M1; OBL 3.0-M12025-10-17
00810099090994Dream Sock Monitoring System - Bedtime BlueOSS 3.0-M1; OBL 3.0-M1 2025-10-17
00810099091007Dream Sock Monitoring System - Dusty Rose OSS 3.0-M1; OBL 3.0-M12025-10-17
00810099091120Dream Sock Monitoring System - Wild ChildOSS 3.0-M1; OBL 3.0-M12025-10-17
00810099091144Dream Sock Monitoring System - Sweet ClementineOSS 3.0-M1; OBL 3.0-M12025-10-17
00810099091229Dream Sock Duo Monitoring System, Blue MistOSS 3.0-M1; OBL 3.0-M12025-10-17
00810099091236Dream Sock Duo Monitoring System, MintOSS 3.0-M1; OBL 3.0-M12025-10-17
00810099091243Dream Sock Duo Monitoring System, Bedtime BlueOSS 3.0-M1; OBL 3.0-M12025-10-17
00810099091250Dream Sock Duo Monitoring System, Dusty RoseOSS 3.0-M1; OBL 3.0-M12025-10-17
00810099091267Dream Sock Duo Monitoring System, Sweet ClementineOSS 3.0-M1; OBL 3.0-M12025-10-17
00810099090826Dream Sock App3.02024-02-12
00810099091212Dream Sock Monitoring System - Blue MistOSS 3.0-M1; OBL 3.0-M12025-05-27
00810099090024 BabySat 3 Rx Base StationOBL 3.0-M1 2024-01-08
00810099090031BabySat 3 Rx SensorOSS 3.0-M12024-01-08
00810099090086BabySat Monitoring SystemOSS 3.0-M1; OBL 3.0-M12024-01-08
00810099090079BabySat 3 Rx App2.23.02024-01-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06947656119813VIAMEDGuangzhou Berrcom Medical Device Co., LtdSDV2026-11-04
06970289035946hetaidaHetaida Technology Co., LtdSDV2026-10-16
06970289035953hetaidaHetaida Technology Co., LtdSDV2026-10-16
06970289035960hetaidaHetaida Technology Co., LtdSDV2026-10-16
06970289035977hetaidaHetaida Technology Co., LtdSDV2026-10-16
00850078377388iHealthiHealth Labs Inc.SDV2026-10-12
00845717012188TrackstarVERIDIAN HEALTHCARE LLCSDV2026-09-04
00311917086569WalgreensWALGREEN CO.SDV2026-08-21
00311917086590WalgreensWALGREEN CO.SDV2026-08-21
00810110303812NuvomedNUVOMED, INC.SDV2026-08-19
00810110305014NuvomedNUVOMED, INC.SDV2026-08-19
06933257923157YUWELL® Infrared ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-08-19
06933257952744YUWELL® Infrared ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-08-19
06933257952751YUWELL® Infrared ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-08-19
06942284618080JOYTECHJOYTECH HEALTHCARE CO.,LTDSDV2026-08-14
10197344219575MEDLINEMEDLINE INDUSTRIES, INC.SDV2026-07-24
00860015688927HomedicsFKA DISTRIBUTING CO., LLCSDV2026-05-31
06933257929432YUWELL® Infrared Ear ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-05-07
06933257930711YUWELL® Infrared Ear ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-05-07
06933257931213YUWELL® Infrared Ear ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-05-07
06933257931244YUWELL® Infrared Ear ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-05-07
06933257931251YUWELL® Infrared Ear ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-05-07
06933257931268YUWELL® Infrared Ear ThermometerJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.SDV2026-05-07
10840330706558ProCureTwin Med, LLCSDV2026-05-05
10840330706565ProCureTwin Med, LLCSDV2026-05-05
00860015673107Inito InTemp Basal ThermometerInito Health, Inc.SDV2026-04-08
04719003406516MicrolifeMICROLIFE USA, INC.SDV2026-01-31
04719883871350Fore HealthFORTECHGRP CO., LTD.SDV2026-01-28
04719883871374Fore HealthFORTECHGRP CO., LTD.SDV2026-01-28
04719883871381Fore HealthFORTECHGRP CO., LTD.SDV2026-01-28