FDA.reportPublic FDA data

Salivette®

Primary DI
04038917168830
Brand
Salivette®
Company
Sarstedt Aktiengesellschaft & Co.KG
Model
51.1534
Catalog number
51.1534
Published
2022-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NNKCONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNKContainer, Specimen Mailer And Storage, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038917086905PrimaryGS10
04038917168830Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038917086905040389170869054038917086905
04038917168830040389171688304038917168830

GMDN Terms#

Term, Definition table
TermDefinition
Oral/upper respiratory tract specimen collection kitA collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for subsequent laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture]. The kit consists of a non-suctioning sampling/collection tool(s) [e.g., swab, brush, spatula, saliva collection mouthpiece/funnel] and a covered specimen receptacle with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)257-5101customerservice.us@sarstedt.com

Regulatory Flags#

DUNS number
388000270
Device count
100
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
04038917085519S-Monovette®-Needle85.116085.11602016-09-16
04038917086370S-Monovette®-Needle85.137285.13722016-09-16
04038917086387S-Monovette®-Needle85.137385.13732016-09-16
04038917086653S-Monovette®-Needle85.144085.14402016-09-16
04038917086660S-Monovette®-Needle85.144185.14412016-09-16
04038917126021Safety-Needle85.1160.20085.1160.2002016-09-16
04038917126045Safety-Needle85.1162.20085.1162.2002016-09-16
04038917127943Safety-Needle85.1372.20085.1372.2002016-09-16
04038917127950Safety-Needle85.1373.20085.1373.2002016-09-16
04038917129190Safety-Needle85.1440.20085.1440.2002016-09-16
04038917129206Safety-Needle85.1441.20085.1441.2002016-09-16
04038917250474Safety-Needle85.1162.60085.1162.6002016-09-16
04038917530590Safety-Needle 23Gx1"85.1442.20085.1442.2002025-05-02
04038917085526S-Monovette®-Needle85.116285.11622016-09-16
0403891739991310ml TBE 100x16 PP RED SCW CAP51.9923.83051.9923.8302023-01-18
04038917429948Tube 10ml, 100x16mm, PP62.9924.28062.9924.2802023-01-18
04066916044077Tube with cap, 82x13mm60.550.14160.550.1412025-09-26
04038917167918Haemo-Diff®14.121814.12182025-09-25
04038917983259S-Monovette® 1.6ml Serum CAT04.291104.29112025-09-25
04038917983280S-Monovette® 1.6ml Serum CAT04.2911.00104.2911.0012025-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30860013988020500 Single strip cards and 500 foil-LifelineADVANCE DX, INC.NNK2026-03-03
30860013988037500 Blood Collection Card (500 Double strip cards and 500 foil-Lifeline)ADVANCE DX, INC.NNK2026-03-03
20860013988047Advance Dx 100 Blood Collection Card (single strip cards and 100 foil)ADVANCE DX, INC.NNK2026-03-03
30860013988051Advance Dx 500 Blood Collection Card (500 single strip cards and 500 foil)ADVANCE DX, INC.NNK2026-03-03
10860013988064Advance Dx Blood Collection Card: Single strip cards - no lines on the frontADVANCE DX, INC.NNK2026-03-03
10860013988071Advance Dx Blood Collection Card: Double Strip cardsADVANCE DX, INC.NNK2026-03-03
00860013988081Advance Dx Blood Collection Card: Triple-Single Strip cardsADVANCE DX, INC.NNK2026-03-03
10860013988095Advance Dx Blood Collection Card: Double-Double Strip cardsADVANCE DX, INC.NNK2026-03-03
B24280EZDEV21000Unfilled Easy 2 Stool Extraction DeviceAMERICAN LABORATORY PRODUCTS COMPANY, LTD.NNK2026-02-02
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80827989007792Health Care Logistics, Inc®Health Care Logistics, Inc.NNK2025-12-19
00859410006351SalimetricsSALIMETRICS, LLCNNK2025-12-10
00859410006368SalimetricsSALIMETRICS, LLCNNK2025-12-10
06975025177478BabioJinan Babio Biotechnology Co., Ltd.NNK2025-09-29
040669160437422.0ml SC Micro Tube protein LBSarstedt Aktiengesellschaft & Co.KGNNK2025-09-25
04066916044534SCMTube 0,5 mlSarstedt Aktiengesellschaft & Co.KGNNK2025-09-25
50810010894897Aero-MedAERO-MED, LLCNNK2025-09-11
00860013988005Advance Dx 100 Blood Collection CardADVANCE DX, INC.NNK2025-08-28
00860013988012Blood Specimen Return BagADVANCE DX, INC.NNK2025-08-28
50810010894750Aero-MedAERO-MED, LLCNNK2025-08-13
50810010894767Aero-MedAERO-MED, LLCNNK2025-08-13
00810185250011TherapakTherapak LLCNNK2025-08-11
00810185250219TherapakTherapak LLCNNK2025-08-11
00810185250356TherapakTherapak LLCNNK2025-08-11
00810185250615TherapakTherapak LLCNNK2025-08-11
00810185250653TherapakTherapak LLCNNK2025-08-11
00810185250578TherapakTherapak LLCNNK2025-08-04
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G669CNBOX1CNS0Crow's Nest Biopsy Catchment SystemCorramedical Inc.NNK2025-07-09
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