Sunmark
GUDID 10010939953886
FPPL Sunmark DPS +/-
MCKESSON CORPORATION
Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid| Primary Device ID | 10010939953886 |
| NIH Device Record Key | 2f9a08f1-7610-407f-8198-a6d51a048157 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sunmark |
| Version Model Number | One Step Pregnancy Test |
| Company DUNS | 177667227 |
| Company Name | MCKESSON CORPORATION |
| Device Count | 2 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | true |
Customer Support Contacts
| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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| Phone | 1-800-899-7353 |
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Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00010939953889 [Primary] |
| GS1 | 00633472000133 [Unit of Use] |
| GS1 | 10010939953886 [Package] Contains: 00010939953889 Package: Shipping Case [24 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K042280
FDA Product Code
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-06 |
| Device Publish Date | 2020-09-28 |
On-Brand Devices [Sunmark]
| 40387030015418 | A hand-held battery powered electronic instrument designed for oral, underarm or rectal use to m |
| 40387030015401 | A hand-held battery powered, electronic instrument designed for oral, underarm or rectal use to |
| 10038703919081 | BP3BR1-1SMARK |
| 10038703919067 | BPMU1-2ESMARK |
| 10038703919050 | BP3MR1-1HSMARK |
| 40038703001183 | A hand-held, battery-powered, electronic instrument designed for oral, under arm or rectal use t |
| 40038703000704 | A hand-held, battery-powered, electronic instrument designed for oral, under arm or rectal use t |
| 40010939494441 | A hand-held, battery-powered, electronic instrument designed to measure a patient's body tempera |
| 00387030022807 | A hand-held battery powered electronic instrument designed to measure a patient's body temperatu |
| 60038703929535 | Heating Pad |
| 40038703000070 | 50 pack of probe covers. A device intended to be used as a physical barrier between the patient |
| 40010939343442 | A hand-held, battery-powered, electronic instrument designed for oral, under arm or rectal use t |
| 40010939325448 | A hand-held, battery-powered, electronic instrument designed for oral, under arm or rectal use t |
| 10010939953824 | BP3NU1-3ESMARK |
| 10010939953817 | BP3NP1-3ESMARK |
| 10010939953787 | BP3NG1-1ASMARK |
| 10010939953800 | BP3MV1-3BSMARK |
| 10010939953794 | BP3NM1-3WSMARK |
| 10010939953831 | BPAG1-20SMARK |
| 10010939953886 | FPPL Sunmark DPS +/- |
| 10010939953879 | Sunmark SPS +/- Blue Cap |
| 00010939938442 | 93844 |
Trademark Results [Sunmark]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SUNMARK 88281141 not registered Live/Pending |
McKesson Corporation 2019-01-29 |
 SUNMARK 87359329 5251362 Live/Registered |
Sunmark Federal Credit Union 2017-03-06 |
 SUNMARK 87359318 5251361 Live/Registered |
Sunmark Federal Credit Union 2017-03-06 |
 SUNMARK 87346569 5251345 Live/Registered |
Sunmark Federal Credit Union 2017-02-23 |
 SUNMARK 78533138 not registered Dead/Abandoned |
Alliance Trading, Inc. 2004-12-15 |
 SUNMARK 78262394 not registered Dead/Abandoned |
McKesson Corporation 2003-06-13 |
 SUNMARK 78262219 2941616 Live/Registered |
McKesson Corporation 2003-06-13 |
 SUNMARK 76208712 2506945 Dead/Cancelled |
Sun Chemical Corporation 2001-02-12 |
 SUNMARK 74428035 1930198 Dead/Cancelled |
Sunmark Holding Company, Inc. 1993-08-24 |
 SUNMARK 73679352 1484600 Dead/Cancelled |
SUNMARK CAPITAL RESOURCES 1987-08-19 |
 SUNMARK 73641658 1459500 Dead/Cancelled |
SUNMARK HOLDING COMPANY, INCORPORATED 1987-01-28 |
 SUNMARK 73430786 1318985 Dead/Cancelled |
Foremost-McKesson, Inc. 1983-06-17 |
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