1 |
00814247020727 |
VPBB15014100 |
|
BoogieBaby nasal aspirator – standard tip with cover
|
BYY |
Tube, Aspirating, Flexible, Connecting
|
|
BoogieBaby nasal aspirator – standard tip with cover |
2 |
00814247020680 |
VPBB15011100 |
|
BoogieBaby nasal aspirator – preemie tip
|
BYY |
Tube, Aspirating, Flexible, Connecting
|
|
BoogieBaby nasal aspirator – preemie tip |
3 |
00814247020444 |
ROM-6000 |
|
ROM Plus® Complete Kit Fetal Membranes Rupture Test
|
NQM |
Immunoassay For Detection Of Amniotic Fluid Protein(S).
|
1 |
ROM Plus®, Fetal Membranes Rupture Collection Kit |
4 |
30814247020346 |
PRS-0530 |
|
Traxi Panniculus Retractor with Retentus Technology (BMI 30-50)
|
CCX |
Support, Patient Position
|
|
traxi® Panniculus Retractorhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetai |
5 |
00814247020147 |
DSD-2000 |
|
ClearView accessory - Disposable Sound Dilator
|
LKF |
Cannula, Manipulator/Injector, Uterine
|
2 |
ClearView |
6 |
00814247020130 |
DSD-1000 |
|
Sound/Dilator (accessory for ClearView Uterine Manipulator)
|
LKF |
Cannula, Manipulator/Injector, Uterine
|
|
ClearView |
7 |
00814247021083 |
VPBB150112100 |
|
BoogieBaby nasal aspirator – olive tip 4.5 inch long
|
BYY |
Tube, Aspirating, Flexible, Connecting
|
|
BoogieBaby nasal aspirator – olive tip 4.5 inch long |
8 |
00814247020734 |
VPBB15015100 |
|
BoogieBaby nasal aspirator – flair tip
|
BYY |
Tube, Aspirating, Flexible, Connecting
|
|
BoogieBaby nasal aspirator – flair tip |
9 |
00814247020697 |
VPBB15012100 |
|
BoogieBaby nasal aspirator – preemie tip with cover
|
BYY |
Tube, Aspirating, Flexible, Connecting
|
|
BoogieBaby nasal aspirator – preemie tip with cover |
10 |
00814247020468 |
ROM-QCS |
|
ROM Plus®, Easy Strip Quality Control for Fetal Membranes Rupture Test
|
JJX |
Single (Specified) Analyte Controls (Assayed And Unassayed)
|
1 |
ROM Plus® Strip Quality Control |
11 |
00814247020604 |
UM900 |
|
ClearView Uterine Manipulator, 9cm
|
LKF |
Cannula, Manipulator/Injector, Uterine
|
2 |
ClearView Uterine Manipulator |
12 |
00814247020482 |
UM202 |
|
ClearView Uterine Manipulator, long tip
|
LKF |
Cannula, Manipulator/Injector, Uterine
|
2 |
ClearView Uterine Manipulator |
13 |
00814247020475 |
UM201 |
|
ClearView Uterine Manipulator, regular tip
|
LKF |
Cannula, Manipulator/Injector, Uterine
|
2 |
ClearView Uterine Manipulator |
14 |
00814247021090 |
VPBB150113100 |
|
BoogieBaby nasal aspirator – olive tip 3.25 inch long
|
BYY |
Tube, Aspirating, Flexible, Connecting
|
|
BoogieBaby nasal aspirator – olive tip 3.25 inch long |
15 |
00814247020857 |
ROM-6025 |
|
ROM Plus Cassette/Collection Kit
|
NQM |
Immunoassay For Detection Of Amniotic Fluid Protein(S).
|
1 |
ROM Plus, Quality Control for Fetal Membranes Rupture Tes |
16 |
00814247020451 |
ROM-QC |
|
ROM Plus®, Quality Control for Fetal Membranes Rupture Test
|
JJX |
Single (Specified) Analyte Controls (Assayed And Unassayed)
|
1 |
ROM Plus® Quality Control Kit |
17 |
00814247020284 |
KDT-1000 |
|
Koala Toco® Single-Use Tocodyamometer
|
HFM |
Monitor, Uterine Contraction, External (For Use In Clinic)
|
2 |
Koala Toco® |
18 |
00814247020017 |
UM700 |
|
ClearView Uterine Manipulator, 7cm
|
LKF |
Cannula, Manipulator/Injector, Uterine
|
2 |
ClearView Uterine Manipulator |
19 |
00814247020666 |
VAC-6000S |
|
Kiwi® Vacuum Delivery System ProCup®
|
HDB |
Extractor, Vacuum, Fetal
|
2 |
Kiwi® ProCup® |
20 |
00814247021106 |
VPBB150114100 |
|
BoogieBaby nasal aspirator – olive tip 4.5 inch with cover
|
BYY |
Tube, Aspirating, Flexible, Connecting
|
|
BoogieBaby nasal aspirator – olive tip 4.5 inch with cover |
21 |
00814247020802 |
PRS-EVAL |
|
Traxi Panniculus Retractor with Retentus Technology
|
CCX |
Support, Patient Position
|
|
traxi® Panniculus Retractor |
22 |
00814247020345 |
PRS-1030 |
|
Traxi Panniculus Retractor with Retentus Technology (BMI 30-50)
|
CCX |
Support, Patient Position
|
1 |
traxi® Panniculus Retractor |
23 |
00814247020659 |
VAC-6000MTE |
|
Kiwi® Vacuum Delivery System, OmniCup® with Traction Force Indicator
|
HDB |
Extractor, Vacuum, Fetal
|
2 |
Kiwi® OmniCup® |
24 |
00814247020642 |
VAC-6000MT |
|
Kiwi® Vacuum Delivery System, OmniCup® with Traction Force Indicator
|
HDB |
Extractor, Vacuum, Fetal
|
2 |
Kiwi® OmniCup® |
25 |
00814247020635 |
VAC-6000ME |
|
Kiwi® Vacuum Delivery System, OmniCup®
|
HDB |
Extractor, Vacuum, Fetal
|
2 |
Kiwi® OmniCup® |
26 |
00814247020628 |
VAC-6000C |
|
Kiwi® Vacuum Delivery System, Omni-C Cup® for Cesarean Section
|
HDB |
Extractor, Vacuum, Fetal
|
2 |
Kiwi® Omni-C Cup® |
27 |
00814247020611 |
UM950 |
|
ClearView Total Uterine Manipulator, 9cm tip
|
LKF |
Cannula, Manipulator/Injector, Uterine
|
2 |
ClearView Total Uterine Manipulator |
28 |
00814247020499 |
UM750 |
|
ClearView Total Uterine Manipulator, regular tip (7cm)
|
LKF |
Cannula, Manipulator/Injector, Uterine
|
|
ClearView Total Uterine Manipulator |
29 |
00814247020710 |
VPBB15013100 |
|
BoogieBaby nasal aspirator – standard tip
|
BYY |
Tube, Aspirating, Flexible, Connecting
|
|
BoogieBaby nasal aspirator – standard tip |
30 |
00814247020437 |
ROM-5025 |
|
ROM Plus® Complete Kit Fetal Membranes Rupture Test
|
NQM |
Immunoassay For Detection Of Amniotic Fluid Protein(S).
|
1 |
ROM Plus®, Fetal Membranes Rupture Test |
31 |
00814247020420 |
ROM-5000 |
|
ROM Plus® Complete Test Kit
|
NQM |
Immunoassay For Detection Of Amniotic Fluid Protein(S).
|
1 |
ROM Plus®, Fetal Membranes Rupture Test |
32 |
00814247020406 |
ROM-1025 |
|
ROM Plus® Easy Strip Complete Kit Fetal Membranes Rupture Test
|
NQM |
Immunoassay For Detection Of Amniotic Fluid Protein(S).
|
|
ROM Plus®, Fetal Membranes Rupture Test |
33 |
00814247020093 |
CIRC-1350 |
|
AccuCirc® Circumcision Device
|
HFX |
Clamp, Circumcision
|
2 |
AccuCirc® |
34 |
00814247020079 |
CIRC-1300 |
|
AccuCirc® Circumcision Device
|
HFX |
Clamp, Circumcision
|
2 |
AccuCirc® |
35 |
00814247020055 |
CIRC-1150 |
|
AccuCirc® Circumcision Device
|
HFX |
Clamp, Circumcision
|
2 |
AccuCirc® |
36 |
00814247020031 |
CIRC-1100 |
|
AccuCirc® Circumcision Device
|
HFX |
Clamp, Circumcision
|
|
AccuCirc® |
37 |
00814247020000 |
VAC-6000M |
|
Kiwi® Vacuum Delivery System, OmniCup®
|
HDB |
Extractor, Vacuum, Fetal
|
2 |
Kiwi® OmniCup® |
38 |
00814247020369 |
PRS-1050 |
|
Traxi Extender (BMI>50 - used with PH-25)
|
CCX |
Support, Patient Position
|
1 |
traxi® Panniculus Retractor Extender |
39 |
00814247020277 |
IPC-5090 |
|
Cables to IUP catheters: Edan F6
|
HFN |
Transducer, Pressure, Intrauterine
|
2 |
Koala® Cables |
40 |
00814247020260 |
IPC-5080 |
|
Cables to IUP catheters: Philips Avalon
|
HFN |
Transducer, Pressure, Intrauterine
|
2 |
Koala® Cables |
41 |
00814247020246 |
IPC-5060 |
|
Cables to IUP catheters: Neoventa
|
HFN |
Transducer, Pressure, Intrauterine
|
2 |
Koala® Cables |
42 |
00814247020239 |
IPC-5050 |
|
Cables to IUP catheters: Space Labs Medical 94000
|
HFN |
Transducer, Pressure, Intrauterine
|
2 |
Koala® Cables |
43 |
00814247020222 |
IPC-5018 |
|
Cables to IUP catheters: HP8040A 40mV
|
HFN |
Transducer, Pressure, Intrauterine
|
2 |
Koala® Cables |
44 |
00814247020215 |
IPC-5016 |
|
Cables to IUP catheters: Litton Air-Shields Fetascan 1400
|
HFN |
Transducer, Pressure, Intrauterine
|
2 |
Koala® Cables |
45 |
00814247020208 |
IPC-5014 |
|
Cables to IUP catheters: GE Coro 115/116/118
|
HFN |
Transducer, Pressure, Intrauterine
|
2 |
Koala® Cables |
46 |
00814247020192 |
IPC-5012 |
|
Cables to IUP catheters: HP8040A 5mV/1350
|
HFN |
Transducer, Pressure, Intrauterine
|
2 |
Koala® Cables |
47 |
30814247020360 |
PRS-0550 |
|
Traxi Extender with Retentus Technology (BMI>50 - used with PH-25)
|
CCX |
Support, Patient Position
|
|
traxi® Panniculus Retractor Extender |
48 |
00814247020598 |
SBT-7019 |
|
Cables to FSE
|
HGP |
Electrode, Circular (Spiral), Scalp And Applicator
|
2 |
FSE Cables |
49 |
00814247020581 |
SBT-7018 |
|
Cables to FSE
|
HGP |
Electrode, Circular (Spiral), Scalp And Applicator
|
2 |
FSE Cables |
50 |
00814247020574 |
SBT-7017 |
|
Cables to FSE
|
HGP |
Electrode, Circular (Spiral), Scalp And Applicator
|
2 |
FSE Cables |