FDA.reportPublic FDA data

Access Medical Probes

Primary DI
10854758006206
Brand
Access Medical Probes
Company
TARRY MEDICAL PRODUCTS, INC.
Model
D-208-700/FC100
Catalog number
D208-700/FC100
Device description
D-208-700/FC100 Single Use Skin Temperature Probe
Published
2018-09-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMZIncubator, Neonatal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMZIncubator, NeonatalGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071977000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071977000TARRY MEDICAL TEMPERATURE PROBESTarry Medical Products, Inc.2008-05-23FMZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10854758006206PackageGS150In Commercial Distribution
00854758006209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085475800620610854758006206
00854758006209008547580062098547580062090854758006209

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose patient temperature probe, single-useA temperature sensing device intended to be placed into a body orifice or on the body surface, and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
203-794-1438customerservice@tarrymfg.com

Regulatory Flags#

DUNS number
107260002
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
10810031980410Tarry Temperature Probe CoverT 80153T 801532020-09-28
10810031980434Tarry Temperature Probe CoverT 80207T 80207 B502020-09-28
10810031980465Tarry Temperature Probe CoverT 80450T 80450 B1002020-09-28
10810031980892Access Medical Probe CoverD-HH-100D-HH-1002020-10-30
20810031980400Tarry Temperature Probe CoverT 80152T 801522020-09-28
20810031980431Tarry Temperature Probe CoverT 80207T 80207 B2002020-09-28
00854758006001Tarry ProbesT 100T 1002016-09-20
00854758006179Access Medical ProbesD-209-20-HHD-209-20-HH2018-09-13
00854758006193Access Medical ProbesD-DP208-700HHD-DP208-700HH2018-09-13
00854758006209Access Medical ProbesD-208-700/FC100D208-700/FC1002018-09-13
10810031980427Tarry Temperature Probe CoverT 80202T 80202 B502020-09-28
10810031980441Tarry Temperature Probe CoverT 80212T 80212 B502020-09-28
10810031980458Tarry Temperature Probe CoverT 20217T 80217 B502020-09-28
20810031980424Tarry Temperature Probe CoverT 80202T 80202 B2002020-09-28
20810031980448Tarry Temperature Probe CoverT 80212T 80212 B2002020-09-28
20810031980455Tarry Temperature Probe CoverT 80217T 80217 B2002020-09-28
00854758006032Tarry ProbesT 10415T 104152016-09-20
00854758006049Tarry ProbesT 11000T 110002016-09-20
00854758006117Tarry ProbesT 08730PT 08730P2016-09-20
00854758006018Tarry ProbesT 3000T 30002016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048675641308Babyleo TN500Drägerwerk AG & Co. KGaAFMZ2026-03-23
10889483577363AirLife™AirLife Finland OyFMZ2025-03-26
10889483577370AirLife™AirLife Finland OyFMZ2025-03-26
20889483577360AirLife™AirLife Finland OyFMZ2025-03-26
20889483577377AirLife™AirLife Finland OyFMZ2025-03-26
10889483577387AirLife™AirLife Finland OyFMZ2025-03-26
B510A31860ADVANCED NEONATAL INCUBATORADVANCED INSTRUMENTATIONS, INC.FMZ2025-02-07
B510A31861ADVANCED NEONATAL INCUBATORADVANCED INSTRUMENTATIONS, INC.FMZ2025-02-07
B510A4051ADVANCED INFANT WARMERADVANCED INSTRUMENTATIONS, INC.FMZ2025-02-07
04942962610858V-2200 Infant Incubator ATOM MEDICAL CORPORATIONFMZ2024-10-29
04942962616102Neo-Servo i Atom Infant Incubator Model 102ATOM MEDICAL CORPORATIONFMZ2024-10-29
04942962674065V-2100G Advanced Infant Incubator ATOM MEDICAL CORPORATIONFMZ2024-10-29
04048675436607Babyleo TN500Drägerwerk AG & Co. KGaAFMZ2024-03-09
00860007476310ATOM Medical USA, Disposable ProbeAtom Medical Usa, LLCFMZ2022-02-08
00195278358363GIRAFFE PANDA DISPOSABLE SKIN TEMPERATUREDatex-Ohmeda, Inc.FMZ2021-11-10
00763000374716Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSFMZ2021-05-21
00763000374723Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSFMZ2021-05-21
00763000374730Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSFMZ2021-05-21
10190752179608AirlifeAirLife Finland OyFMZ2021-02-26
10190752179615AirlifeAirLife Finland OyFMZ2021-02-26
20190752179605AirlifeVYAIRE MEDICAL, INC.FMZ2021-02-26
70190752179617AirlifeVYAIRE MEDICAL, INC.FMZ2021-02-26
10190752179622AirlifeAirLife Finland OyFMZ2021-02-26
10190752106130Multi-Link™AirLife Finland OyFMZ2021-01-13
10190752106147Multi-Link™AirLife Finland OyFMZ2021-01-13
20190752106137Multi-Link™Vyaire Medical OyFMZ2021-01-13
20190752106144Multi-Link™Vyaire Medical OyFMZ2021-01-13
10190752106161Multi-Link™AirLife Finland OyFMZ2021-01-13
00643169912199Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSFMZ2019-06-08
00643169912205Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSFMZ2019-06-08