FDA.reportPublic FDA data

NA

Primary DI
20888551042489
Brand
NA
Company
STERILMED, INC.
Model
MAS1860-9
Catalog number
MAS1860-9
Device description
ADHESIVE SENSOR LNCS PDTX PEDIATRIC 10-50(KG) WITH 9-PIN CONNECTOR
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NLFOXIMETER, REPROCESSED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NLFOximeter, ReprocessedCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092368000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092368000REPROCESSED PULSE OXIMETER SENSORSSterilmed, Inc.2009-11-03NLF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888551042489PackageGS124In Commercial Distribution
10888551042482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088855104248920888551042489
1088855104248210888551042482

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, reprocessedA photoelectric device applied externally to a body site, e.g., a fingertip, ear lobe, the bridge of nose, a toe, or the bridge of the foot of a paediatric or adult patient for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using light detection. The signals, produced by a light-emitting diode (LED) and a receiving detector, are received by an oximeter to which this device is connected. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(888)541-0078customerservice@sterilmed.com
+1(888)541-0078sterilmedcs@its.jnj.com

Regulatory Flags#

DUNS number
175899459
Device count
1
DM exempt
false
Premarket exempt
false
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
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888551001205NAMED5455SLMED5455SL2016-09-22
10888551004312NAMID7BA407BA402018-06-18
10888551004329NAMID7BA40D7BA40D2018-06-18
10888551017862NALIN5052-1865052-1862018-06-18
10888551035224NASTR1608-2-111608-2-112018-06-18
10888551045292NASYN03.312.090SYN03.312.0902019-11-15
10888551045308NASYN03.312.120SYN03.312.1202019-11-15
10888551045315NASYN394.88SYN394.882019-11-15
10888551045322NASYN03.312.680SYN03.312.6802019-11-15
10888551045339NASYN394.89SYN394.892019-11-15
10888551045346NASYN394.90SYN394.902019-11-15
10888551045353NASYN394.91SYN394.912019-11-15
10888551045360NASYN394.92SYN394.922019-11-15
10888551045377NASYN03.312.620SYN03.312.6202019-11-15
10888551045384NASYN03.312.650SYN03.312.6502019-11-15
10888551045391NASYN03.312.710SYN03.312.7102019-11-15
10888551045407NASYN03.312.740SYN03.312.7402019-11-15
10888551045414NASYN03.312.590SYN03.312.5902019-11-15
10888551045421NASYN03.312.350SYN03.312.3502019-11-15
10888551045438NASYN03.312.380SYN03.312.3802019-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816317023997Nellcor Pulse Oximeter ProbeRENU MEDICAL, INCNLF2025-07-08
10816317023994Nellcor Pulse Oximeter ProbeRENU MEDICAL, INCNLF2025-07-08
10193489020458MEDLINEMEDLINE INDUSTRIES, INC.NLF2025-01-29
10884389185339MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLF2025-01-29
10884389185346MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLF2025-01-29
10888277185326MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLF2025-01-29
10888277306356MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLF2025-01-29
10888277306363MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLF2025-01-29
10193489020441MEDLINEMEDLINE INDUSTRIES, INC.NLF2025-01-02
20193489020448MEDLINEMEDLINE INDUSTRIES, INC.NLF2025-01-02
10888277722309MedlineMEDLINE INDUSTRIES, INC.NLF2023-10-09
20888277722306MedlineMEDLINE INDUSTRIES, INC.NLF2023-10-09
00816317024109Pulse Oximeter ProbeRENU MEDICAL, INCNLF2023-08-21
10816317024106Pulse Oximeter ProbeRENU MEDICAL, INCNLF2023-08-21
00816317023492MasimoRENU MEDICAL, INCNLF2023-06-29
00816317023973MasimoRENU MEDICAL, INCNLF2023-06-29
10816317023499MasimoRENU MEDICAL, INCNLF2023-06-29
10816317023970MasimoRENU MEDICAL, INCNLF2023-06-29
07613327610543Stryker Sustainability SolutionsSTRYKER SUSTAINABILITY SOLUTIONS, INC.NLF2023-02-07
07613327610550Stryker Sustainability SolutionsSTRYKER SUSTAINABILITY SOLUTIONS, INC.NLF2023-02-07
07613327610567Stryker Sustainability SolutionsSTRYKER SUSTAINABILITY SOLUTIONS, INC.NLF2023-02-07
07613327610574Stryker Sustainability SolutionsSTRYKER SUSTAINABILITY SOLUTIONS, INC.NLF2023-02-07
37613327610544Stryker Sustainability SolutionsSTRYKER SUSTAINABILITY SOLUTIONS, INC.NLF2023-02-07
57613327610555Stryker Sustainability SolutionsSTRYKER SUSTAINABILITY SOLUTIONS, INC.NLF2023-02-07
57613327610562Stryker Sustainability SolutionsSTRYKER SUSTAINABILITY SOLUTIONS, INC.NLF2023-02-07
57613327610579Stryker Sustainability SolutionsSTRYKER SUSTAINABILITY SOLUTIONS, INC.NLF2023-02-07
10817357020011NellcorHYGIA HEALTH SERVICES, INC.NLF2016-09-24
10817357020028NellcorHYGIA HEALTH SERVICES, INC.NLF2016-09-24
10817357020059MasimoHYGIA HEALTH SERVICES, INC.NLF2016-09-24
10817357020097MasimoHYGIA HEALTH SERVICES, INC.NLF2016-09-24